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FDA 510(k) Application Details - K993673
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K993673
Device Name
Neurological Stereotaxic Instrument
Applicant
I.S.G. TECHNOLOGIES, INC.
6509 AIRPORT ROAD
MISSISSAUGA, ONTARIO L4V 1S7 CA
Other 510(k) Applications for this Company
Contact
DOLORES MCGIRR
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/01/1999
Decision Date
12/21/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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