FDA 510(k) Application Details - K112599

Device Classification Name Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

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510(K) Number K112599
Device Name Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Applicant INSURGICAL LLC
8708 CAPEHART COVE
AUSTIN, TX 78733 US
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Contact DAVID C FURR
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Regulation Number 000.0000

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Classification Product Code KIJ
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Date Received 09/07/2011
Decision Date 11/06/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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