PROSYS SAMEC LA— 510(k) K963265

Name: FDA 510(k) clearance K963265
Creator: U.S. Food and Drug Administration
Published: 1996-10-25

Substantially Equivalent

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

FDA 510(k) clearance K963265 for PROSYS SAMEC LA, Substantially Equivalent on 1996-10-25. 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: 1996-08-20
Decision date: 1996-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, 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.