FDA 510(k) Application Details - K072666

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K072666
Device Name Sleeve, Limb, Compressible
Applicant BIO COMPRESSION SYSTEMS, INC.
P.O. BOX 470218
BROADVIEW HEIGHTS, OH 44141 US
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Contact JAMES JOCHEN ROGERS
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 09/21/2007
Decision Date 11/05/2007
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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