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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 K031397
Device Name MERLIN E-MASK
Applicant
MERLIN MEDICAL LIMITED
THE WHITBREAD CENTRE,RHYMNEY,
GWENT
UNITED KINGDOM,  GB NP22 5BF
Applicant Contact ROBERT STEELE
Correspondent
MERLIN MEDICAL LIMITED
THE WHITBREAD CENTRE,RHYMNEY,
GWENT
UNITED KINGDOM,  GB NP22 5BF
Correspondent Contact ROBERT STEELE
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/02/2003
Decision Date 07/29/2004
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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