FDA 510(k) Application Details - K971978

Device Classification Name Blade, Saw, General & Plastic Surgery, Surgical

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510(K) Number K971978
Device Name Blade, Saw, General & Plastic Surgery, Surgical
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact CRISTIE MANUEL
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Regulation Number 878.4820

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Classification Product Code GFA
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Date Received 05/29/1997
Decision Date 06/18/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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