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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 K854231
Device Name ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES
Applicant
Clinical Technology Corp.
3750 Monroe Ave.
P.O. Box 23245
Rochester,  NY  14692
Applicant Contact JOHN SCOVILLE
Correspondent
Clinical Technology Corp.
3750 Monroe Ave.
P.O. Box 23245
Rochester,  NY  14692
Correspondent Contact JOHN SCOVILLE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/21/1985
Decision Date 05/02/1986
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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