EMERGENCY RESPONSE SAFETY KIT— 510(k) K946001

Substantially Equivalent

Ani Safety, Inc.

FDA 510(k) clearance K946001 for EMERGENCY RESPONSE SAFETY KIT, Substantially Equivalent on 1995-06-09. Applicant: Ani Safety, Inc..

Clearance details

Applicant: Ani Safety, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1994-11-21
Decision date: 1995-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

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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.