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FDA 510(k) Application Details - K090530
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K090530
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
ROSS CREEK MEDICAL INC.
14734 LA RINCONADA DRIVE
LOS GATOS, CA 95032 US
Other 510(k) Applications for this Company
Contact
MICHAEL KOLBER
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
02/27/2009
Decision Date
05/20/2009
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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