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FDA 510(k) Application Details - K053051
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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510(K) Number
K053051
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND, FL 33815 US
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TRISH STEPHENS
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Regulation Number
888.3030
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Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
10/28/2005
Decision Date
12/22/2005
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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