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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sizer, Heart-Valve, Prosthesis
510(k) Number K952184
Device Name CARBOMEDICS SUPRA-ANNULAR VALVE SIZER
Applicant
Carbomedics, Inc.
1300-A E. Anderson Ln.
Austin,  TX  78752
Applicant Contact JOY F SHUGART
Correspondent
Carbomedics, Inc.
1300-A E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact JOY F SHUGART
Regulation Number870.3945
Classification Product Code
DTI  
Date Received05/09/1995
Decision Date 11/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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