DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM— 510(k) K950784

Name: FDA 510(k) clearance K950784
Creator: U.S. Food and Drug Administration
Published: 1995-05-03

Substantially Equivalent

Advanced Bioresearch Assoc.

FDA 510(k) clearance K950784 for DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM, Substantially Equivalent on 1995-05-03. Applicant: Advanced Bioresearch Assoc.. Device class: 1.

Clearance details

Applicant: Advanced Bioresearch Assoc.
Product code: Code EYQ
Device class: Class 1
Regulation: 21 CFR 876.5920
Advisory panel: Gastroenterology, Urology
Date received: 1995-02-21
Decision date: 1995-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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