EPIVIEW— 510(k) K961319

Name: FDA 510(k) clearance K961319
Creator: U.S. Food and Drug Administration
Published: 1996-07-08

Substantially Equivalent

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

FDA 510(k) clearance K961319 for EPIVIEW, Substantially Equivalent on 1996-07-08. Applicant: Convatec, A Division of E.R. Squibb & Sons. Device class: Unclassified.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Product code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1996-04-05
Decision date: 1996-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MGP

product code MGP

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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