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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 K872705
Device Name BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT)
Applicant
Clinical Technology Corp.
3750 Monroe Ave.
P.O. Box 23245
Rochester,  NY  14692
Applicant Contact SCOVILLE, JR.
Correspondent
Clinical Technology Corp.
3750 Monroe Ave.
P.O. Box 23245
Rochester,  NY  14692
Correspondent Contact SCOVILLE, JR.
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/07/1987
Decision Date 09/01/1987
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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