FDA 510(k) Application Details - K970280

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K970280
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant FERGUSON MEDICAL
3407 BAY AVE.
CHICO, CA 95973-8619 US
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Contact FRANK FERGUSON
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 01/23/1997
Decision Date 05/22/1997
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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