Cleared Traditional

AMSINO URINARY LEG BAG

K971929 · Amsino Intl., Inc. · Gastroenterology & Urology
Aug 1997
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K971929 is an FDA 510(k) clearance for the AMSINO URINARY LEG BAG, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Amsino Intl., Inc. (Pomona, US). The FDA issued a Cleared decision on August 6, 1997, 71 days after receiving the submission on May 27, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K971929 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 1997
Decision Date August 06, 1997
Days to Decision 71 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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