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FDA 510(k) Application Details - K955257
Device Classification Name
Stimulator, Electrical, Evoked Response
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510(K) Number
K955257
Device Name
Stimulator, Electrical, Evoked Response
Applicant
AXON SYSTEMS, INC.
400-2200 OSER AVE.
HAUPPAUGE, NY 11788 US
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Contact
HOWARD BAILIN
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Regulation Number
882.1870
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Classification Product Code
GWF
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More FDA Info for this Product Code
Date Received
11/07/1995
Decision Date
02/02/1996
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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