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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 K844565
Device Name BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT)
Applicant
Clinical Technology Corp.
3750 Monroe Ave.
P.O. Box 23245
Rochester,  NY  14692
Applicant Contact ELAINE C JEVELI
Correspondent
Clinical Technology Corp.
3750 Monroe Ave.
P.O. Box 23245
Rochester,  NY  14692
Correspondent Contact ELAINE C JEVELI
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/23/1984
Decision Date 02/21/1985
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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