4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050— 510(k) K950392

Name: FDA 510(k) clearance K950392
Creator: U.S. Food and Drug Administration
Published: 1995-02-21

Substantially Equivalent

Cal West Trading Co.

FDA 510(k) clearance K950392 for 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050, Substantially Equivalent on 1995-02-21. Applicant: Cal West Trading Co.. Device class: 2.

Clearance details

Applicant: Cal West Trading Co.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1995-02-01
Decision date: 1995-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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