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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 K083418
Device Name CPR MASK
Applicant
Firstar Healthcare Co., Ltd.
3500 S. Dupont Hwy.
Dover,  DE  19901
Applicant Contact YOVETTE MUMFORD
Correspondent
Firstar Healthcare Co., Ltd.
3500 S. Dupont Hwy.
Dover,  DE  19901
Correspondent Contact YOVETTE MUMFORD
Regulation Number868.5870
Classification Product Code
CBP  
Date Received11/18/2008
Decision Date 07/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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