FDA 510(k) Application Details - K021324

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K021324
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
3 HASADNOAT ST.
HERZLIA 46728 IL
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Contact YAEL RUBIN
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 04/26/2002
Decision Date 05/23/2002
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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