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FDA 510(k) Application Details - K964869
Device Classification Name
Stimulator, Nerve
More FDA Info for this Device
510(K) Number
K964869
Device Name
Stimulator, Nerve
Applicant
THE MAGSTIM COMPANY LTD.
SPRING GARDENS, WHITLAND
DYFED, WALES SA34 OHR GB
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Contact
C. HOVEY
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
12/04/1996
Decision Date
05/14/1997
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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