Company · US

Kentron Health Care, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2003. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
FYC	Gown, Isolation, Surgical	2
EFQ	Gauze/Sponge, Internal	1
FLK	Thermometer, Clinical Mercury	1
GDY	Gauze/Sponge, Internal, X-Ray Detectable	1
HIB	Speculum, Vaginal, Nonmetal	1

Decided	510(k)	Device and applicant	Code
Aug 27, 2003	K030693	KENTEX DISPOSABLE VAGINAL SPECULUM Kentron Health Care, Inc.	HIB
Sep 19, 1997	K972410	IMPERVIOUS ISOLATION GOWN Kentron Health Care, Inc.	FYC
Sep 19, 1997	K971917	KENTRON'S ISOLATION GOWN Kentron Health Care, Inc.	FYC
Dec 15, 1995	K953465	KENTEMP Kentron Health Care, Inc.	FLK
Nov 6, 1995	K953914	KENTEX Kentron Health Care, Inc.	EFQ
Oct 3, 1995	K953830	KENSORB Kentron Health Care, Inc.	GDY

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.