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FDA 510(k) Application Details - K980820
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K980820
Device Name
Neurological Stereotaxic Instrument
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
710 BRIDGEPORT AVE.
P.O. BOX 860
SHELTON, CT 06484 US
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Contact
FRANK GIANELLI
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
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More FDA Info for this Product Code
Date Received
03/03/1998
Decision Date
10/13/1998
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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