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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 K071744
Device Name AVIAFIT PULSATING LEGBAND
Applicant
Flowmedic , Ltd.
20 Hataas St.
P.O.B. 124
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Flowmedic , Ltd.
20 Hataas St.
P.O.B. 124
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/27/2007
Decision Date 09/25/2007
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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