FDA 510(k) Application Details - K001938

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K001938
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant VECTOR MEDICAL, INC.
1886 LODGEPOLE DR.
MILTON, FL 32583 US
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Contact ERIN MCGURK
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 06/26/2000
Decision Date 08/29/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K001938


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