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FDA 510(k) Application Details - K072095
Device Classification Name
Nail, Fixation, Bone
More FDA Info for this Device
510(K) Number
K072095
Device Name
Nail, Fixation, Bone
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER, PA 19380 US
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Contact
JILL SHERMAN
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/31/2007
Decision Date
09/27/2007
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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