FDA 510(k) Application Details - K021929

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K021929
Device Name Instrument, Ultrasonic Surgical
Applicant AXYA MEDICAL, INC.
100 CUMMINGS CENTER
SUITE 444C
BEVERLY, MA 01915 US
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Contact HOWARD L SCHRAYER
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 06/12/2002
Decision Date 09/10/2002
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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