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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
Applicant Contact SUE OSTER
Correspondent
Synergetics, Inc.
88 Hubble Dr.
St. Charles,  MO  63304
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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