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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 K993628
Device Name OMNISONICS ULTRASONIC PROBES
Applicant
Omnisonics Medical Technologies
7 Tiffany Trail
Hopkonton,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Omnisonics Medical Technologies
7 Tiffany Trail
Hopkonton,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Classification Product Code
LFL  
Date Received10/27/1999
Decision Date 12/15/1999
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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