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510(k) Premarket Notification

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Device Classification Name sleeve, limb, compressible
510(k) NumberK043423
Device NameMODEL SC-3008 SEQUENTIAL CIRCULATOR
Applicant
BIO COMPRESSION SYSTEMS, INC.
120 west commercial ave.
moonachie,  NJ  07074
Contactron motherwell
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/13/2004
Decision Date 02/01/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
 
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