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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K864146
Device Name DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)
Applicant
Cardio Thoracic Systems
10600 N. Tantau Ave.
Cupertino,  CA  95014
Applicant Contact MICHAEL J BILLIG
Correspondent
Cardio Thoracic Systems
10600 N. Tantau Ave.
Cupertino,  CA  95014
Correspondent Contact MICHAEL J BILLIG
Regulation Number878.4750
Classification Product Code
GDW  
Date Received10/22/1986
Decision Date 11/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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