FDA 510(k) Application Details - K063688

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

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510(K) Number K063688
Device Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Applicant THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS, FL 33410 US
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Contact JIM BANIC
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Regulation Number 878.4820

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Classification Product Code HWE
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Date Received 12/12/2006
Decision Date 01/16/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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