FDA 510(k) Application Details - K960711

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

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510(K) Number K960711
Device Name Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Applicant ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON, OR 97005 US
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Contact SHARI L JEFFERS
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Regulation Number 000.0000

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Classification Product Code KIJ
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Date Received 02/21/1996
Decision Date 05/07/1996
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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