ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSE— 510(k) K933817

Substantially Equivalent

Renaissance Medical, Inc.

FDA 510(k) clearance K933817 for ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSE, Substantially Equivalent on 1994-01-10. Applicant: Renaissance Medical, Inc..

Clearance details

Applicant: Renaissance Medical, Inc.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1993-08-04
Decision date: 1994-01-10
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.