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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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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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