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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 K051831
Device Name GEMINI SURGICAL CONTROL & DISPLAY SYSTEM
Applicant
Applied Surgical, LLC
300 Riverchase Pkwy. E.
Birmingham,  AL  35244
Applicant Contact DAVID A ALEXANDER
Correspondent
Applied Surgical, LLC
300 Riverchase Pkwy. E.
Birmingham,  AL  35244
Correspondent Contact DAVID A ALEXANDER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/06/2005
Decision Date 09/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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