FDA 510(k) Application Details - K955397

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K955397
Device Name Neurological Stereotaxic Instrument
Applicant NOMOS CORP.
2591 WEXFORD BAYNE RD.
SUITE 400
SEWICKLEY, PA 15143 US
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Contact MARVIN L SUSSMAN
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 11/24/1995
Decision Date 04/30/1996
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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