FDA 510(k) Application Details - K993019

Device Classification Name Neurosurgical Paddie

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510(K) Number K993019
Device Name Neurosurgical Paddie
Applicant V. MUELLER NEURO/SPINE
360 INDUSTRIAL RD., UNIT H
SAN CARLOS, CA 94070 US
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Contact TERRY JOHNSTON
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Regulation Number 882.4700

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Classification Product Code HBA
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Date Received 09/08/1999
Decision Date 03/30/2000
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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