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FDA 510(k) Application Details - K083609
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K083609
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
KFX MEDICAL
5845 AVENIDA ENCINAS,SUITE 128
CARLSBAD, CA 92008 US
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Contact
GAYLE HIROTA
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/08/2008
Decision Date
03/06/2009
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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