BURNSHIELD TRAUMA DRESSING— 510(k) K952247

Name: FDA 510(k) clearance K952247
Creator: U.S. Food and Drug Administration
Published: 1995-07-26

Substantially Equivalent

Golightly International Corp.

FDA 510(k) clearance K952247 for BURNSHIELD TRAUMA DRESSING, Substantially Equivalent on 1995-07-26. Applicant: Golightly International Corp.. Device class: Unclassified.

Clearance details

Applicant: Golightly International Corp.
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1995-05-11
Decision date: 1995-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hingham, MA, 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.