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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K950392
Device Name 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050
Applicant
Cal West Trading Co.
231 E. Emerson Ave.
Orange,  CA  92665
Applicant Contact VICENT CHAN
Correspondent
Cal West Trading Co.
231 E. Emerson Ave.
Orange,  CA  92665
Correspondent Contact VICENT CHAN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received02/01/1995
Decision Date 02/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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