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FDA 510(k) Application Details - K981820
Device Classification Name
Electrode, Depth
More FDA Info for this Device
510(K) Number
K981820
Device Name
Electrode, Depth
Applicant
RADIONICS, INC.
22 TERRY AVE.
BURLINGTON, MA 01803-2516 US
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Contact
JEFFREY R MANNION
Other 510(k) Applications for this Contact
Regulation Number
882.1330
More FDA Info for this Regulation Number
Classification Product Code
GZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/22/1998
Decision Date
11/20/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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