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FDA 510(k) Application Details - K070294
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K070294
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER, PA 19380 US
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Contact
SHERI L MUSGNUNG
Other 510(k) Applications for this Contact
Regulation Number
888.3020
More FDA Info for this Regulation Number
Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/31/2007
Decision Date
03/01/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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