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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 K052458
Device Name LIV MEDICA CPR FACE MASK
Applicant
Liv Medica Products Pvt. , Ltd.
458 Briarcreek Dr.
Hockessin,  DE  19707
Applicant Contact MICHAEL HOLSTEIN
Correspondent
Liv Medica Products Pvt. , Ltd.
458 Briarcreek Dr.
Hockessin,  DE  19707
Correspondent Contact MICHAEL HOLSTEIN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received09/07/2005
Decision Date 07/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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