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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 K933756
Device Name MAGNASHIELD CPR MOUTH BARRIER
Applicant
Cal West Trading Co.
231 E. Emerson Ave.
Orange,  CA  92665
Applicant Contact ANDY CHAO
Correspondent
Cal West Trading Co.
231 E. Emerson Ave.
Orange,  CA  92665
Correspondent Contact ANDY CHAO
Regulation Number868.5870
Classification Product Code
CBP  
Date Received08/03/1993
Decision Date 01/05/1994
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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