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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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