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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 K020220
Device Name ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
Applicant
SYNERGETICS, INC.
88 HUBBLE DR.
ST. CHARLES,  MO  63304 -8694
Applicant Contact SUE OSTER
Correspondent
SYNERGETICS, INC.
88 HUBBLE DR.
ST. CHARLES,  MO  63304 -8694
Correspondent Contact SUE OSTER
Classification Product Code
LFL  
Date Received01/22/2002
Decision Date 08/23/2002
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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