FDA 510(k) Application Details - K943855

Device Classification Name Nail, Fixation, Bone

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510(K) Number K943855
Device Name Nail, Fixation, Bone
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 888.3030

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Classification Product Code JDS
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Date Received 08/08/1994
Decision Date 07/12/1995
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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