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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aortic Annuloplasty Ring
510(k) Number K163608
Device Name HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm
Applicant
Biostable Science & Engineering, Inc.
2621 Ridgepoint Dr., Suite 100
Austin,  TX  78754
Applicant Contact Julie Thomas
Correspondent
Hogan Lovells US LLP
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number870.3800
Classification Product Code
PST  
Date Received12/21/2016
Decision Date 03/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01400841
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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