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FDA 510(k) Application Details - K952294
Device Classification Name
Stimulator, Electrical, Evoked Response
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510(K) Number
K952294
Device Name
Stimulator, Electrical, Evoked Response
Applicant
COMPUTATIONAL DIAGNOSTICS, INC.
5001 BAUM BLVD., SUITE 426
PITTSBURGH, PA 15213 US
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SHARON ENOS
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Regulation Number
882.1870
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Classification Product Code
GWF
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Date Received
05/16/1995
Decision Date
01/26/1996
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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