STERILE WOUND HYDROGEL DRESSING— 510(k) K941339

Substantially Equivalent

Renaissance Pharmaceutical, Inc.

FDA 510(k) clearance K941339 for STERILE WOUND HYDROGEL DRESSING, Substantially Equivalent on 1994-06-10. Applicant: Renaissance Pharmaceutical, Inc..

Clearance details

Applicant: Renaissance Pharmaceutical, Inc.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1994-03-21
Decision date: 1994-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dana Point, CA, US

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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.