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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 K060220
Device Name PBS MODEL 701A COMPRESSION THERAPY DEVICE
Applicant
Mego Afek
Beit Hapa'Amon (Box 124)
20 Hata'As St.,
Kfar Saba,  IL 44425
Applicant Contact AHAVA M STEIN
Correspondent
Mego Afek
Beit Hapa'Amon (Box 124)
20 Hata'As St.,
Kfar Saba,  IL 44425
Correspondent Contact AHAVA M STEIN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received01/30/2006
Decision Date 02/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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