FDA 510(k) Application Details - K061507

Device Classification Name Plate, Bone

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510(K) Number K061507
Device Name Plate, Bone
Applicant KLS-MARTIN L.P.
11239 ST. JOHNS INDUSTRIAL
PARKWAY SOUTH
JACKSONVILLE, FL 32246 US
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Contact JENNIFER DAMATO
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 06/01/2006
Decision Date 09/21/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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