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FDA 510(k) Application Details - K031493
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K031493
Device Name
Plate, Fixation, Bone
Applicant
UNIVERSITY OF UTAH/SCHOOL OF MEDICINE
P.O. BOX #58246
SALT LAKE CITY, UT 84158 US
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Contact
PETER M STEVENS
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
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More FDA Info for this Product Code
Date Received
05/12/2003
Decision Date
11/20/2003
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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