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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 K954426
Device Name CPR LIFE MASK COMPACT BARRIER
Applicant
CAREFREE TRADING, INC.
14602 NORTH CAVE CREEK RD.,
SUITE B
PHOENIX,  AZ  85022
Applicant Contact RICK STOCKETT
Correspondent
CAREFREE TRADING, INC.
14602 NORTH CAVE CREEK RD.,
SUITE B
PHOENIX,  AZ  85022
Correspondent Contact RICK STOCKETT
Regulation Number868.5870
Classification Product Code
CBP  
Date Received09/22/1995
Decision Date 09/16/1996
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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