PROSYS URIHESIVE SYSTEM LA— 510(k) K951530

Name: FDA 510(k) clearance K951530
Creator: U.S. Food and Drug Administration
Published: 1995-05-12

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K951530 for PROSYS URIHESIVE SYSTEM LA, Substantially Equivalent on 1995-05-12. Applicant: Convatec, A Division of E.R. Squibb & Sons. Device class: 1.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Code EXJ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1995-04-03
Decision date: 1995-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.