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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Ultrasonic Instruments
510(k) Number K855138
Device Name BOVIE ULTRASONIC SURGICAL SYSTEM
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
Classification Product Code
LBK  
Date Received12/23/1985
Decision Date 11/10/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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