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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K953824
Device Name LIFEMASK FACE SHIELD
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 Number868.5915
Classification Product Code
BTM  
Date Received08/15/1995
Decision Date 09/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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