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FDA 510(k) Application Details - K081586
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K081586
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
STERILMED, INC.
11140 73RD AVE. NORTH
MINNEAPOLIS, MN 55369 US
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Contact
JOSHUA CLARIN
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
06/05/2008
Decision Date
08/18/2008
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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