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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 K121962
Device Name PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
Applicant
MEGO AFEK AC LTD
KIBBUTZ AFEK
AFEK,  IL 30042
Applicant Contact ALEX RAPEL
Correspondent
MEGO AFEK AC LTD
KIBBUTZ AFEK
AFEK,  IL 30042
Correspondent Contact ALEX RAPEL
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/05/2012
Decision Date 10/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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