FDA 510(k) Application Details - K961425

Device Classification Name Pack, Hot Or Cold, Water Circulating

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510(K) Number K961425
Device Name Pack, Hot Or Cold, Water Circulating
Applicant BIO COMPRESSION SYSTEMS, INC.
P.O. BOX 470218
BROADVIEW HEIGHTS, OH 44147 US
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Contact DANIEL A KRACOV
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Regulation Number 890.5720

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Classification Product Code ILO
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Date Received 04/12/1996
Decision Date 10/28/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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