PROCEL BURN COVER— 510(k) K915695

Name: FDA 510(k) clearance K915695
Creator: U.S. Food and Drug Administration
Published: 1992-05-29

Substantially Equivalent for Some Indications

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K915695 for PROCEL BURN COVER, Substantially Equivalent for Some Indications on 1992-05-29. Applicant: W. L. Gore & Associates, Inc.. Device class: Unclassified.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1991-12-23
Decision date: 1992-05-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Flagstaff, AZ, 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.