FDA 510(k) Application Details - K051724

Device Classification Name Neurological Stereotaxic Instrument

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510(K) Number K051724
Device Name Neurological Stereotaxic Instrument
Applicant EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY, NJ 07054 US
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Contact WHITNEY TORNING
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Regulation Number 882.4560

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Classification Product Code HAW
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Date Received 06/27/2005
Decision Date 07/19/2005
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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