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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 K974170
Device Name DUOSTAR
Applicant
Mti Corp./ Electrostar S.A.-Haiti
1183 Ceda St.
Safety Harbor,  FL  34695
Applicant Contact C. T HARDY
Correspondent
Mti Corp./ Electrostar S.A.-Haiti
1183 Ceda St.
Safety Harbor,  FL  34695
Correspondent Contact C. T HARDY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/05/1997
Decision Date 09/30/1998
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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