FDA 510(k) Application Details - K041659

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K041659
Device Name Sleeve, Limb, Compressible
Applicant C-BOOT LTD.
8 MARVA STREET
CARMIEL 21691 IL
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Contact AVI ABRAHAM
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 06/18/2004
Decision Date 10/28/2004
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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