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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 K010309
Device Name SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
Applicant
MUTOH AMERICA CO., LTD.
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL] KAMM
Correspondent
MUTOH AMERICA CO., LTD.
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL] KAMM
Classification Product Code
LFL  
Date Received02/01/2001
Decision Date 04/18/2001
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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