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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K031434
Device Name BAWMED E-Z BAG RESUSCITATOR
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 Number868.5915
Classification Product Code
BTM  
Date Received05/06/2003
Decision Date 02/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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