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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 K910663
Device Name BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR
Applicant
Mdt Corp., Inc.
1777 E. Henrietta Rd.(14623)
P.O. Box 23077
Rochester,  NY  14692
Applicant Contact MARK SMITH
Correspondent
Mdt Corp., Inc.
1777 E. Henrietta Rd.(14623)
P.O. Box 23077
Rochester,  NY  14692
Correspondent Contact MARK SMITH
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/14/1991
Decision Date 05/09/1991
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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