Cleared Traditional

URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)

K962652 · Customed, Inc. · Gastroenterology & Urology
Oct 1996
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K962652 is an FDA 510(k) clearance for the URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749), a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on October 4, 1996, 88 days after receiving the submission on July 8, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K962652 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1996
Decision Date October 04, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KNX — Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5250

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