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FDA 510(k) Application Details - K053141
Device Classification Name
Stimulator, Nerve
More FDA Info for this Device
510(K) Number
K053141
Device Name
Stimulator, Nerve
Applicant
THE MAGSTIM COMPANY LTD.
SPRING GARDENS
WHITLAND, DYFED WALES SA34 OHR GB
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Contact
CHRIS LEWIS
Other 510(k) Applications for this Contact
Regulation Number
874.1820
More FDA Info for this Regulation Number
Classification Product Code
ETN
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More FDA Info for this Product Code
Date Received
11/09/2005
Decision Date
12/14/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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