CUSTOMED BASIC PACK III— 510(k) K902886

Clearance details

Applicant

Customed, Inc.

Product code

Code KKX

Device class

Class 2

Regulation

21 CFR 878.4370

Advisory panel

General, Plastic Surgery

Date received

1990-07-02

Decision date

1990-09-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carolina Puerto Rico, US

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• Z-1397-2016 — Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.Class II·Terminated·Customed, Inc·20160107
• Z-1430-2016 — Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.Class II·Terminated·Customed, Inc·20160107
• Z-1437-2016 — Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.Class II·Terminated·Customed, Inc·20160107
• Z-1445-2016 — Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.Class II·Terminated·Customed, Inc·20160107
• Z-1466-2016 — Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.Class II·Terminated·Customed, Inc·20160107
• Z-2594-2015 — LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .Class II·Terminated·Customed, Inc·20150710
• Z-2596-2015 — UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .Class II·Terminated·Customed, Inc·20150710
• Z-2606-2015 — MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .Class II·Terminated·Customed, Inc·20150710
• Z-2608-2015 — UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .Class II·Terminated·Customed, Inc·20150710
• Z-2615-2015 — ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .Class II·Terminated·Customed, Inc·20150710
• Z-2627-2015 — SURGICAL PACK 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .Class II·Terminated·Customed, Inc·20150710

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K902886.