FACE PROTECTION PAK(TM)— 510(k) K894905

Substantially Equivalent

Protech Products

FDA 510(k) clearance K894905 for FACE PROTECTION PAK(TM), Substantially Equivalent on 1989-09-12. Applicant: Protech Products.

Clearance details

Applicant: Protech Products
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1989-08-01
Decision date: 1989-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, AL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.