FDA 510(k) Application Details - K990717

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K990717
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004-1109 US
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Contact JONATHAN S KAHAN
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 03/04/1999
Decision Date 06/02/1999
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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