M-K HYDROGEL DRESSING— 510(k) K940409

Name: FDA 510(k) clearance K940409
Creator: U.S. Food and Drug Administration
Published: 1994-07-11

Substantially Equivalent for Some Indications

Mason-Keller Corp.

FDA 510(k) clearance K940409 for M-K HYDROGEL DRESSING, Substantially Equivalent for Some Indications on 1994-07-11. Applicant: Mason-Keller Corp.. Device class: Unclassified.

Clearance details

Applicant: Mason-Keller Corp.
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1994-01-27
Decision date: 1994-07-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Roseland, NJ, US

Download summary PDF View on FDA.gov ↗

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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.