FDA 510(k) Application Details - K133304

Device Classification Name Plate, Bone

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510(K) Number K133304
Device Name Plate, Bone
Applicant KLS-MARTIN L.P.
11201 Saint Johns Industrial Pkwy S
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 10/28/2013
Decision Date 05/15/2014
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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