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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 K012753
Device Name SORING GMBH SONOCA 180/190
Applicant
Soring GmbH Medizintechnik
1100 Lakeview Blvd.
Denton,  TX  76208
Applicant Contact CARL ALLETTO
Correspondent
Soring GmbH Medizintechnik
1100 Lakeview Blvd.
Denton,  TX  76208
Correspondent Contact CARL ALLETTO
Classification Product Code
LFL  
Date Received08/16/2001
Decision Date 11/13/2001
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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