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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 K932094
Device Name BOVIE ULTRASONIC SURGICAL ASPIRATOR
Applicant
Mdt Corp., Inc.
2471 E. Shadow Wood Cr.
P.O. Box 17801
Salt Lake City,  UT  84117
Applicant Contact DONALD F GRABARZ
Correspondent
Mdt Corp., Inc.
2471 E. Shadow Wood Cr.
P.O. Box 17801
Salt Lake City,  UT  84117
Correspondent Contact DONALD F GRABARZ
Classification Product Code
LFL  
Date Received04/30/1993
Decision Date 07/21/1993
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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