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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 K133957
Device Name DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
Applicant
GALEMED CORP.
AMOY EXPORT PROCESSING ZONE, 39
SECTION 3, HAIJING EAST RD
XIAMEN, FUJIAN,  CN 361000
Applicant Contact PAUL DRYDEN
Correspondent
GALEMED CORP.
AMOY EXPORT PROCESSING ZONE, 39
SECTION 3, HAIJING EAST RD
XIAMEN, FUJIAN,  CN 361000
Correspondent Contact PAUL DRYDEN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received12/23/2013
Decision Date 04/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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