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FDA 510(k) Application Details - K170312
Device Classification Name
Motor, Drill, Electric
More FDA Info for this Device
510(K) Number
K170312
Device Name
Motor, Drill, Electric
Applicant
MEDTRONIC POWERED SURGICAL SOLUTIONS
4620 NORTH BEACH ST
FORT WORTH, TX 76137 US
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Contact
DEEP PAL
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Regulation Number
882.4360
More FDA Info for this Regulation Number
Classification Product Code
HBC
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More FDA Info for this Product Code
Date Received
02/01/2017
Decision Date
05/15/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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