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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sleeve, limb, compressible
510(k) Number K160318
Device Name PlasmaFlow
Applicant
MANAMED, INC
287 CABRILLO ST.
UNIT C
Costa Mesa,  CA  92627
Applicant Contact Trevor Theriot
Correspondent
THIRD PARTY REVIEW GROUP, LLC
45 ROCKEFELLER PLAZA
SUITE 2000
NEW YORK,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number870.5800
Classification Product Code
JOW  
Date Received02/05/2016
Decision Date 04/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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