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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K021051
Device Name ANNULOFLO SYSTEM, MITRAL MODEL AR700
Applicant
Sulzer Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Applicant Contact TEFFANY HANKINSON
Correspondent
Sulzer Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact TEFFANY HANKINSON
Regulation Number870.3800
Classification Product Code
KRH  
Date Received04/01/2002
Decision Date 04/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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