FDA 510(k) Application Details - K961120

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K961120
Device Name Neurological Stereotaxic Instrument
Applicant HOWMEDICA LEIBINGER, INC.
14540 BELTWOOD PARKWAY EAST
DALLAS, TX 75244 US
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Contact ANDREW B ROGERS
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 03/21/1996
Decision Date 05/10/1996
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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