FDA 510(k) Application Details - K022632

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K022632
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant SURGICAL IMPLANT GENERATION NETWORK (SIGN)
2950 GEORGE WASHINGTON WAY
RICHLAND, WA 99352-1615 US
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Contact DOUG DONNELLY
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 08/07/2002
Decision Date 09/23/2002
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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