URINARY DRAINAGE BAG— 510(k) K934142

Name: FDA 510(k) clearance K934142
Creator: U.S. Food and Drug Administration
Published: 1994-05-17

Substantially Equivalent

Key Medical Services, Inc.

FDA 510(k) clearance K934142 for URINARY DRAINAGE BAG, Substantially Equivalent on 1994-05-17. Applicant: Key Medical Services, Inc.. Device class: 2.

Clearance details

Applicant: Key Medical Services, Inc.
Product code: Code EXR
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1993-08-25
Decision date: 1994-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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