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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
Model 901A&901B
Device Name PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
Applicant
MEGO AFEK AC LTD
kibbutz afek
afek, 
Contact alex rapel
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/05/2012
Decision Date 10/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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