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510(k) K950295 · LRO General Surgery Tray

WOUND CLOSURE/LACERATION TRAY

Applicant	Customed, Inc., Fajardo PR, US
Decision	Substantially Equivalent, Apr 18, 1995
Received	Jan 24, 1995
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K950295

Date	Firm and product	Code	Linked 510(k)
Apr 14, 2016	Customed, Inc Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	MCY	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	MCY	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	MCY	None listed
Apr 14, 2016	Customed, Inc Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated	LRO	None listed
Sep 3, 2015	Customed, Inc WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . Terminated	MCY	None listed
Sep 3, 2015	Customed, Inc WOUND CLOSURE TRAY II CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . Terminated	MCY	None listed
Sep 3, 2015	Customed, Inc WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . Terminated	LRO	None listed
Sep 3, 2015	Customed, Inc MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . Terminated	LRO	None listed
Mar 21, 2012	Customed, Inc Minor laceration tray , catalog# 900-1765 Terminated	LRO	None listed
Mar 21, 2012	Customed, Inc Wound Closure Tray I, catalog# 900-063 Terminated	LRO	None listed
Mar 21, 2012	Customed, Inc Wound Closure Tray II, catalog# 900-064 Terminated	LRO	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.