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FDA 510(k) Application Details - K093914
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K093914
Device Name
Plate, Fixation, Bone
Applicant
NEWDEAL SAS
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 US
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Contact
STEPHEN BEIER
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2009
Decision Date
04/14/2011
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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