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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 K050831
Device Name STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A
Applicant
Stellartech Research Corp.
1346 Bordeaux Dr.
Sunnyvale,  CA  94089
Applicant Contact JAMES SANTOS
Correspondent
Stellartech Research Corp.
1346 Bordeaux Dr.
Sunnyvale,  CA  94089
Correspondent Contact JAMES SANTOS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/01/2005
Decision Date 04/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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