FDA 510(k) Application Details - K964402

Device Classification Name Retractor, Self-Retaining, For Neurosurgery

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510(K) Number K964402
Device Name Retractor, Self-Retaining, For Neurosurgery
Applicant V. MUELLER NEURO/SPINE
871 INDUSTRIAL RD.
SAN CARLOS, CA 94070 US
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Contact TERRY JOHNSON
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Regulation Number 882.4800

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Classification Product Code GZT
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Date Received 11/04/1996
Decision Date 01/23/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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