FDA 510(k) Application Details - K981480

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K981480
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
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 04/24/1998
Decision Date 01/28/1999
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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