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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 K971580
Device Name UAS ULTRASONIC ASPIRATOR SYSTEM
Applicant
Wells Johnson Co.
8000 S. Kolb Rd.-85706
P.O. Box 18230
Tucson,  AZ  85731
Applicant Contact BRENDA HUNT
Correspondent
Wells Johnson Co.
8000 S. Kolb Rd.-85706
P.O. Box 18230
Tucson,  AZ  85731
Correspondent Contact BRENDA HUNT
Classification Product Code
LFL  
Date Received04/30/1997
Decision Date 12/09/1997
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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