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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 K082345
Device Name OXYGEN DEMAND VALVE
Applicant
Bpr Medical, Ltd.
22, Hamilton Way
Mansfield, Nottinghamshire,  GB NG18 5BU
Applicant Contact BEN JOHNSON
Correspondent
Bpr Medical, Ltd.
22, Hamilton Way
Mansfield, Nottinghamshire,  GB NG18 5BU
Correspondent Contact BEN JOHNSON
Regulation Number868.5870
Classification Product Code
CBP  
Date Received08/15/2008
Decision Date 03/13/2009
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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