FDA 510(k) Application Details - K150953

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K150953
Device Name Sleeve, Limb, Compressible
Applicant BIO COMPRESSION SYSTEMS, INC.
120 W COMMERCIAL AVE.
MOONACHIE, NJ 07074 US
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Contact Barbara J Whitman
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 04/09/2015
Decision Date 07/16/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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