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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 K133119
Device Name FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
Applicant
Arjohuntleigh Polska SP Z.O.O.
35 Portmanmoor Rd.
Cardiff,  GB CF24 5HN
Applicant Contact DAVID MOYNHAM
Correspondent
Arjohuntleigh Polska SP Z.O.O.
35 Portmanmoor Rd.
Cardiff,  GB CF24 5HN
Correspondent Contact DAVID MOYNHAM
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/30/2013
Decision Date 02/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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