FDA 510(k) Application Details - K091694

Device Classification Name Screw, Fixation, Bone

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510(K) Number K091694
Device Name Screw, Fixation, Bone
Applicant T.A.G. MEDICAL PRODUCTS
291 Hillside Avenue
Somerset, MA 02726 US
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Contact GEORGIE J HATTUB
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 06/10/2009
Decision Date 07/07/2009
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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