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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K160112
Device Name Besmed PEEP Valve
Applicant
Besmed Health Business Corp
#5, Lane 116, Wu-Kong 2nd Rd.
New Taipei City,  TW
Applicant Contact ERIC LI
Correspondent
Besmed Health Business Corp
#5, Lane 116, Wu-Kong 2nd Rd.
New Taipei City,  TW
Correspondent Contact PAUL DRYDEN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received01/19/2016
Decision Date 04/29/2016
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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