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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 K100521
Device Name COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
Applicant
MEGO AFEK AC LTD
20 HATA'AS ST.
KFAR SABA,  IL 44425
Applicant Contact AVAHA STEIN
Correspondent
MEGO AFEK AC LTD
20 HATA'AS ST.
KFAR SABA,  IL 44425
Correspondent Contact AVAHA STEIN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received02/23/2010
Decision Date 05/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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