PROCEL BURN COVER/PROCEL BURN TREATMENT COVER— 510(k) K943280

Name: FDA 510(k) clearance K943280
Creator: U.S. Food and Drug Administration
Published: 1994-08-18

Substantially Equivalent for Some Indications

W.L. Gore & Company, GmbH

FDA 510(k) clearance K943280 for PROCEL BURN COVER/PROCEL BURN TREATMENT COVER, Substantially Equivalent for Some Indications on 1994-08-18. Applicant: W.L. Gore & Company, GmbH. Device class: Unclassified.

Clearance details

Applicant: W.L. Gore & Company, GmbH
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1994-07-07
Decision date: 1994-08-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Putzbrunn, DE

Download summary PDF View on FDA.gov ↗

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K990079 — FASTSEAL CHEST WOUND DRESSING1999-12-23
K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING1999-10-14

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.