CPR MASK & RELATED FAMILY KITS— 510(k) K953461

Name: FDA 510(k) clearance K953461
Creator: U.S. Food and Drug Administration
Published: 1996-01-04

Substantially Equivalent

Safetec of America, Inc.

FDA 510(k) clearance K953461 for CPR MASK & RELATED FAMILY KITS, Substantially Equivalent on 1996-01-04. Applicant: Safetec of America, Inc.. Device class: 2.

Clearance details

Applicant: Safetec of America, Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1995-07-24
Decision date: 1996-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.