DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)— 510(k) K962439

Substantially Equivalent

Richard Hamer Assoc., Inc.

FDA 510(k) clearance K962439 for DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10), Substantially Equivalent on 1996-09-03. Applicant: Richard Hamer Assoc., Inc..

Clearance details

Applicant: Richard Hamer Assoc., Inc.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1996-06-24
Decision date: 1996-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, 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.