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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K061544
Device Name STELLARTECH 100 COAGULATION SYSTEM
Applicant
Stellartech Research Corp.
1350 Bordeaux Dr.
Sunnyvale,  CA  94089
Applicant Contact JAMES R SANTOS
Correspondent
Stellartech Research Corp.
1350 Bordeaux Dr.
Sunnyvale,  CA  94089
Correspondent Contact JAMES R SANTOS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/05/2006
Decision Date 10/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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