FDA 510(k) Application Details - K013449

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K013449
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
3 HASADNAOT
HERZELIA 46728 IL
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Contact ELAD MAGAL
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 10/17/2001
Decision Date 12/19/2001
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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