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FDA 510(k) Application Details - K050706
Device Classification Name
Retractor, Self-Retaining, For Neurosurgery
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510(K) Number
K050706
Device Name
Retractor, Self-Retaining, For Neurosurgery
Applicant
SPINAL CONCEPTS, INC.
5301 RIATA PARK CT., BLDG. F
AUSTIN, TX 78727 US
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NOAH BARTSCH
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Regulation Number
882.4800
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Classification Product Code
GZT
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Date Received
03/18/2005
Decision Date
04/15/2005
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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