FDA 510(k) Application Details - K962952

Device Classification Name Device, Neurosurgical Fragmentation And Aspiration

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510(K) Number K962952
Device Name Device, Neurosurgical Fragmentation And Aspiration
Applicant OLYMPUS OPTICAL, CO.
55 NORTHERN BLVD., SUITE 410
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 000.0000

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Classification Product Code LBK
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Date Received 07/30/1996
Decision Date 11/29/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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