FDA 510(k) Application Details - K010309

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K010309
Device Name Instrument, Ultrasonic Surgical
Applicant MUTOH AMERICA CO., LTD.
PO BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL] KAMM
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 02/01/2001
Decision Date 04/18/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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