FDA 510(k) Application Details - K960534

Device Classification Name Prosthesis, Wrist, Carpal Trapezium

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510(K) Number K960534
Device Name Prosthesis, Wrist, Carpal Trapezium
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact CLIFF R KLINE II
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Regulation Number 888.3770

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Classification Product Code KYI
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Date Received 02/07/1996
Decision Date 02/06/1997
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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