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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 K061857
Device Name MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR
Applicant
Bio Compression Systems, Inc.
P.O. Box 470218
Broadview Heights,  OH  44141
Applicant Contact JAMES JOCHEN ROGERS
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/30/2006
Decision Date 08/01/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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