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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 K131327
Device Name BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
Applicant
Bio Compression Systems, Inc.
1983 Hazelwood Rd.
Oms River,  NJ  08753
Applicant Contact Maureen Garner
Correspondent
Bio Compression Systems, Inc.
1983 Hazelwood Rd.
Oms River,  NJ  08753
Correspondent Contact Maureen Garner
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/08/2013
Decision Date 07/18/2013
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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