FDA 510(k) Application Details - K041168

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K041168
Device Name Filler, Bone Void, Calcium Compound
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact ROGER D BROWN
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 05/04/2004
Decision Date 08/02/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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