MEPILEX— 510(k) K983184

Substantially Equivalent

Molnlycke Health Care, Inc.

FDA 510(k) clearance K983184 for MEPILEX, Substantially Equivalent on 1998-10-28. Applicant: Molnlycke Health Care, Inc..

Clearance details

Applicant: Molnlycke Health Care, Inc.
Product code: Code MGP
Advisory panel: Unknown
Date received: 1998-09-11
Decision date: 1998-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eddystone, PA, US

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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.