FDA 510(k) Application Details - K070360

Device Classification Name Instrument, Ultrasonic Surgical

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510(K) Number K070360
Device Name Instrument, Ultrasonic Surgical
Applicant KIRWAN SURGICAL PRODUCTS, INC.
180 ENTERPRISE DR.
MARSHFIELD, MA 02050 US
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Contact KEVIN P PRARIO
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Regulation Number 000.0000

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Classification Product Code LFL
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Date Received 02/07/2007
Decision Date 08/07/2007
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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