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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 K122330
Device Name FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE
Applicant
ARJOHUNTLEIGH POLSKA SP Z.O.O.
35 PORTMANMOOR ROAD
CARDIFF,  GB CF24 5HN
Applicant Contact DAVID MOYNHAM
Correspondent
ARJOHUNTLEIGH POLSKA SP Z.O.O.
35 PORTMANMOOR ROAD
CARDIFF,  GB CF24 5HN
Correspondent Contact DAVID MOYNHAM
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/02/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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