ANTIFOG— 510(k) K934347

Substantially Equivalent

Norpak Mfg., Inc.

FDA 510(k) clearance K934347 for ANTIFOG, Substantially Equivalent on 1994-01-21. Applicant: Norpak Mfg., Inc..

Clearance details

Applicant: Norpak Mfg., Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1993-09-08
Decision date: 1994-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ajax, Ontario L1z 1e2, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.