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FDA 510(k) Application Details - K010988
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K010988
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
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Contact
JONATHAN S KAHAN
Other 510(k) Applications for this Contact
Regulation Number
888.3020
More FDA Info for this Regulation Number
Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/02/2001
Decision Date
06/19/2001
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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