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FDA 510(k) Application Details - K031510
Device Classification Name
Stimulator, Nerve
More FDA Info for this Device
510(K) Number
K031510
Device Name
Stimulator, Nerve
Applicant
MEDTRONIC XOMED
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216 US
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Contact
MARTIN SARGENT
Other 510(k) Applications for this Contact
Regulation Number
874.1820
More FDA Info for this Regulation Number
Classification Product Code
ETN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/2003
Decision Date
06/18/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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