FDA 510(k) Application Details - K961759

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

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510(K) Number K961759
Device Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Applicant MAILLEFER INSTRUMENTS S.A.
4084 CLIFFROSE AVE.
MOORPARK, CA 93021 US
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Contact LEONARD A LERITZ
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Regulation Number 878.4820

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Classification Product Code HWE
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Date Received 05/07/1996
Decision Date 06/13/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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