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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 K102299
Device Name CPR FACE MASK
Applicant
GENUINE FIRST AID LLC
150 CHERRY LANE RD.
EAST STROUDSBURG,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
GENUINE FIRST AID LLC
150 CHERRY LANE RD.
EAST STROUDSBURG,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number868.5870
Classification Product Code
CBP  
Date Received08/13/2010
Decision Date 03/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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