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FDA 510(k) Application Details - K110763
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K110763
Device Name
Screw, Fixation, Bone
Applicant
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
291 Hillside Avenue
Somerset, MA 02726 US
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Contact
GEORGE J HATTUB
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
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More FDA Info for this Product Code
Date Received
03/18/2011
Decision Date
04/11/2011
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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