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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
Models FG100S, FG200S
Device Name FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE
Original Applicant
ARJOHUNTLEIGH POLSKA SP Z.O.O.
35 portmanmoor road
cardiff,  UK cf24 5hn
Original Contact david moynham
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/02/2012
Decision Date 12/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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