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FDA 510(k) Application Details - K964324
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K964324
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
BONUTTI RESEARCH
1303 EVERGREEN AVE.
EFFINGHAM, IL 62401 US
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Contact
LYNNETTE WHITAKER, RAC
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Regulation Number
888.3040
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Classification Product Code
MBI
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More FDA Info for this Product Code
Date Received
10/30/1996
Decision Date
01/10/1997
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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