FEMALE EXTERNAL URINARY COLLECTION POUCH— 510(k) K971499

Name: FDA 510(k) clearance K971499
Creator: U.S. Food and Drug Administration
Published: 1997-08-28

Substantially Equivalent

Mediquest, Inc.

FDA 510(k) clearance K971499 for FEMALE EXTERNAL URINARY COLLECTION POUCH, Substantially Equivalent on 1997-08-28. Applicant: Mediquest, Inc.. Device class: 1.

Clearance details

Applicant: Mediquest, Inc.
Product code: Code EXI
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-25
Decision date: 1997-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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