FDA 510(k) Application Details - K110259

Device Classification Name Plate, Bone

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510(K) Number K110259
Device Name Plate, Bone
Applicant MEDTRONIC SOFAMOR DANEK USA, INC.
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact KELLY DAVIDSON
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 01/28/2011
Decision Date 04/13/2011
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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