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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 K953461
Device Name CPR MASK & RELATED FAMILY KITS
Applicant
SAFETEC OF AMERICA, INC.
1055 EAST DELAVAN AVE.
BUFFALO,  NY  14215
Applicant Contact ROBERT O DEAN
Correspondent
SAFETEC OF AMERICA, INC.
1055 EAST DELAVAN AVE.
BUFFALO,  NY  14215
Correspondent Contact ROBERT O DEAN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received07/24/1995
Decision Date 01/04/1996
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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