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FDA 510(k) Application Details - K071349
Device Classification Name
Stimulator, Nerve
More FDA Info for this Device
510(K) Number
K071349
Device Name
Stimulator, Nerve
Applicant
THE MAGSTIM COMPANY LTD.
SPRING GARDENS
WHITLAND
CARMARTHENSHIRE, WALES SA34 OHR GB
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Contact
ANWEN EVANS
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
05/14/2007
Decision Date
12/12/2007
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
N
Expedited Review
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