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FDA 510(k) Application Details - K030900
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K030900
Device Name
Screw, Fixation, Bone
Applicant
INION LTD.
LAAKARINKATU 2
TAMPERE 33520 FI
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Contact
HANNA MARTTILA
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
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More FDA Info for this Product Code
Date Received
03/24/2003
Decision Date
06/19/2003
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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