CUSTOMED LAP PACK IV— 510(k) K902031

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

1990-05-04

Decision date

1990-07-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fajardo, PR, US

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• Z-1403-2016 — Catalog Number: 900036 LAPAROTOMY 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-1404-2016 — Catalog Number: 900052 MINOR PROCEDURE 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-1435-2016 — Catalog Number: 900176 LAPAROTOMY 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-1451-2016 — Catalog Number: 9002516 LAPAROTOMY 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-2554-2015 — MAJOR 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. .Class II·Terminated·Customed, Inc·20150710
• Z-2555-2015 — MINOR PROCEDURE PACK 40/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-2610-2015 — LAPAROTOMY PACK CUSTOMED 7/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-2673-2015 — MAJOR LAP PACK 4/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 K902031.