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FDA 510(k) Application Details - K955012
Device Classification Name
Holder, Head, Neurosurgical (Skull Clamp)
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510(K) Number
K955012
Device Name
Holder, Head, Neurosurgical (Skull Clamp)
Applicant
MIZUHO AMERICA, INC.
123 BRIMBAL AVE.
BEVERLY, MA 01915 US
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Contact
LISA SCHWEITZER
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Regulation Number
882.4460
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Classification Product Code
HBL
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More FDA Info for this Product Code
Date Received
11/01/1995
Decision Date
09/12/1996
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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