URINARY DRAINAGE BAG— 510(k) K951597

Name: FDA 510(k) clearance K951597
Creator: U.S. Food and Drug Administration
Published: 1995-08-04

Substantially Equivalent

Key Medical Services, Inc.

FDA 510(k) clearance K951597 for URINARY DRAINAGE BAG, Substantially Equivalent on 1995-08-04. Applicant: Key Medical Services, Inc.. Device class: 1.

Clearance details

Applicant: Key Medical Services, Inc.
Product code: Code EYZ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1995-04-07
Decision date: 1995-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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