FDA 510(k) Application Details - K982570

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K982570
Device Name Neurological Stereotaxic Instrument
Applicant I.S.G. TECHNOLOGIES, INC.
6509 AIRPORT ROAD
MISSISSAUGA, ONTARIO L4V 1S7 CA
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Contact CAROL NAKAGAWA
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 07/23/1998
Decision Date 01/13/1999
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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