FDA 510(k) Application Details - K951673

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K951673
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON, OR US
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Contact SHARI L JEFFERS
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 04/11/1995
Decision Date 07/06/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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