FDA 510(k) Application Details - K130774

Device Classification Name Plate, Fixation, Bone

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510(K) Number K130774
Device Name Plate, Fixation, Bone
Applicant NEWCLIP TECHNICS
1001 OAKWOOD BLVD.
ROUND ROCK, TX 78681 US
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Contact J.D. WEBB
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 03/20/2013
Decision Date 06/19/2013
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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