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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K955257
Device Name SS102 DUAL CHANNEL SEP STIMULATOR
Applicant
AXON SYSTEMS, INC.
400-2200 OSER AVE.
HAUPPAUGE,  NY  11788
Applicant Contact HOWARD BAILIN
Correspondent
AXON SYSTEMS, INC.
400-2200 OSER AVE.
HAUPPAUGE,  NY  11788
Correspondent Contact HOWARD BAILIN
Regulation Number882.1870
Classification Product Code
GWF  
Date Received11/07/1995
Decision Date 02/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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