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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 K020211
Device Name BODY FORCE, MODEL BT 6000
Applicant
Composites Solutions, Inc.
1940 Old Dunbar Rd.
West Columbia,  SC  29172
Applicant Contact RANDY SISK
Correspondent
Composites Solutions, Inc.
1940 Old Dunbar Rd.
West Columbia,  SC  29172
Correspondent Contact RANDY SISK
Regulation Number870.5800
Classification Product Code
JOW  
Date Received01/22/2002
Decision Date 06/28/2002
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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