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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 K031395
Device Name MERLIN RESUSCITATOR
Applicant
MERLIN MEDICAL LIMITED
THE WHITBREAD CENTRE,RHYMNEY,
GWENT
UNITED KINGDOM,  GB NP22 5BF
Applicant Contact ROGERT STEELE
Correspondent
MERLIN MEDICAL LIMITED
THE WHITBREAD CENTRE,RHYMNEY,
GWENT
UNITED KINGDOM,  GB NP22 5BF
Correspondent Contact ROGERT STEELE
Regulation Number868.5915
Classification Product Code
BTM  
Date Received05/02/2003
Decision Date 07/16/2004
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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