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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Heart-Valve, Prosthesis
510(k) Number K942736
Device Name CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE
Applicant
Carbomedics, Inc.
1300-A E. Anderson Ln.
Austin,  TX  78752 -1708
Applicant Contact JOY FISHER SHUGART
Correspondent
Carbomedics, Inc.
1300-A E. Anderson Ln.
Austin,  TX  78752 -1708
Correspondent Contact JOY FISHER SHUGART
Regulation Number870.3935
Classification Product Code
DTJ  
Date Received06/10/1994
Decision Date 07/06/1994
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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