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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 K250974
Device Name Bio Arterial Deluxe (IC-BAP-DX)
Applicant
Bio Compression Systems, Inc.
120 W. Commercial Ave.
Moonachie,  NJ  07074
Applicant Contact Marc Somelofski
Correspondent
Bio Compression Systems, Inc.
120 W. Commercial Ave.
Moonachie,  NJ  07074
Correspondent Contact Marc Somelofski
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/31/2025
Decision Date 12/12/2025
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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