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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K880166
Device Name BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000
Applicant
Clinical Technology Corp.
1212 St. Paul St.
Baltimore,  MD  21202
Applicant Contact FRANK BONADIO
Correspondent
Clinical Technology Corp.
1212 St. Paul St.
Baltimore,  MD  21202
Correspondent Contact FRANK BONADIO
Classification Product Code
LFL  
Date Received01/14/1988
Decision Date 02/18/1988
Decision Substantially Equivalent (SESE)
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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