FDA 510(k) Application Details - K060146

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K060146
Device Name Sleeve, Limb, Compressible
Applicant MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
7 JABOTINSKY STREET
MOSHE AVIV TOWER
RAMAT GAN 52520 IL
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Contact DORIT WINITZ
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 01/19/2006
Decision Date 03/08/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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