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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Water Circulating
510(k) Number K961425
Device Name BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS
Applicant
BIO COMPRESSION SYSTEMS, INC.
P.O. BOX 470218
BROADVIEW HEIGHTS,  OH  44147
Applicant Contact DANIEL A KRACOV
Correspondent
BIO COMPRESSION SYSTEMS, INC.
P.O. BOX 470218
BROADVIEW HEIGHTS,  OH  44147
Correspondent Contact DANIEL A KRACOV
Regulation Number890.5720
Classification Product Code
ILO  
Subsequent Product Code
IRP  
Date Received04/12/1996
Decision Date 10/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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