FDA 510(k) Application Details - K141578

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K141578
Device Name Sleeve, Limb, Compressible
Applicant DEVON MEDICAL
1100 FIRST AVENUE SUITE 202
KING OF PRUSSIA, PA 19406 US
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Contact RUTH WU
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 06/13/2014
Decision Date 06/27/2014
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 Y
Expedited Review



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