HYDROGEL DRESSING— 510(k) K945217

Substantially Equivalent for Some Indications

O.R. Resources, Inc.

FDA 510(k) clearance K945217 for HYDROGEL DRESSING, Substantially Equivalent for Some Indications on 1995-05-12. Applicant: O.R. Resources, Inc..

Clearance details

Applicant: O.R. Resources, Inc.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1994-10-26
Decision date: 1995-05-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Delray Beach, FL, 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.