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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 K983065
Device Name MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM
Applicant
Mentor Corp.
5425 Hollister Ave.
Santa Barbara,  CA  93111
Applicant Contact DONNA A CRAWFORD
Correspondent
Mentor Corp.
5425 Hollister Ave.
Santa Barbara,  CA  93111
Correspondent Contact DONNA A CRAWFORD
Classification Product Code
LFL  
Date Received09/02/1998
Decision Date 12/01/1998
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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