TPN TRAY (STERILE)— 510(k) K925021

Clearance details

Applicant

Customed, Inc.

Product code

Code MCY

Device class

Class 2

Regulation

21 CFR 880.5075

Advisory panel

General Hospital

Date received

1992-09-24

Decision date

1993-06-07

Decision

Unknown

Clearance type

Traditional

Location

Fajardo, PR, US

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• K964011 — SUCTION CATHETER TRAY PRODUCT NO. 9002771996-11-25
• K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)1996-10-04
• K962596 — CUSTOMED BLOOD EXTRACTION KIT1996-09-27

• Z-2593-2015 — DRESSING CHANGE CUSTOMED 50/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 K925021.