FDA 510(k) Application Details - K944946

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

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510(K) Number K944946
Device Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Applicant U.S. MEDICAL PRODUCTS, INC.
912 SOUTH CAPITAL OF TEXAS HWY
SUITE 100
AUSTIN, TX US
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Contact WILLIAM N THOMPSON
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Regulation Number 878.4820

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Classification Product Code HWE
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Date Received 10/07/1994
Decision Date 02/01/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee SU - General & Plastic Surgery
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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