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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 K031431
Device Name BAWMED RESCUE MASK
Applicant
Bawmed UK
6 Great House Meadows
United Kingdom,  GB CF61 ISU.
Applicant Contact BARBARA WOODS
Correspondent
Bawmed UK
6 Great House Meadows
United Kingdom,  GB CF61 ISU.
Correspondent Contact BARBARA WOODS
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/06/2003
Decision Date 07/13/2004
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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