FDA 510(k) Application Details - K141489

Device Classification Name Plate, Fixation, Bone

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510(K) Number K141489
Device Name Plate, Fixation, Bone
Applicant KLS MARTIN L.P.
11201 SAINT JOHNS INDUSTRIAL
PARKWAY SOUTH
JACKSONVILLE, FL 32246 US
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Contact JENNIFER DAMATO
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 06/05/2014
Decision Date 07/24/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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