4 SURE URINARY LEG BAG— 510(k) K896728

Name: FDA 510(k) clearance K896728
Creator: U.S. Food and Drug Administration
Published: 1990-02-20

Substantially Equivalent

The Boston & Pacific Co., Inc.

FDA 510(k) clearance K896728 for 4 SURE URINARY LEG BAG, Substantially Equivalent on 1990-02-20. Applicant: The Boston & Pacific Co., Inc.. Device class: 1.

Clearance details

Applicant: The Boston & Pacific Co., Inc.
Product code: Code FAQ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-29
Decision date: 1990-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hingham, MA, US

Download summary PDF View on FDA.gov ↗

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