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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K142640
Device Name Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator
Applicant
Bio Compression Systems, Inc.
120 W. Commercial Ave.
Moonachie,  NJ  07074
Applicant Contact Barbara Whitman
Correspondent
Bio Compression Systems, Inc.
120 W. Commercial Ave.
Moonachie,  NJ  07074
Correspondent Contact Barbara Whitman
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/17/2014
Decision Date 11/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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