510(k) K902191 ยท KKX Drape, Surgical, Antimicrobial
CUSTOMED LAP PACK II
| Applicant | Customed, Inc., Carolina Puerto Rico, US |
| Decision | Substantially Equivalent, Oct 31, 1990 |
| Received | May 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902191
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2016 | Customed, Inc Catalog Number: 900796
FEMORAL ANGIOGRAPHY SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, et Terminated |
OEQ | None listed |
| Sep 3, 2015 | Customed, Inc LAPAROTOMY PK 4/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 FEMORAL ANGIOGRAPHY PACK 4/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OEQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.