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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 K003824
Device Name OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI
Applicant
Omnisonics Medical Technologies
66 Concord St., Suite A
Wilmington,  MA  01887
Applicant Contact DOUG CHARLAND
Correspondent
Omnisonics Medical Technologies
66 Concord St., Suite A
Wilmington,  MA  01887
Correspondent Contact DOUG CHARLAND
Classification Product Code
LFL  
Date Received12/11/2000
Decision Date 03/08/2001
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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