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FDA 510(k) Application Details - K050346
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K050346
Device Name
Screw, Fixation, Bone
Applicant
NEWDEAL S.A.
311 ENTERPRISE DRIVE
PLAINSBORO, NJ 08536 US
Other 510(k) Applications for this Company
Contact
JUDITH E O'GRADY
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/11/2005
Decision Date
03/17/2005
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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