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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, depth
510(k) Number K970943
Device Name GUIDELINE SYSTEM
Applicant
AXON INSTRUMENTS, INC.
1101 CHESS DR.
FOSTER CITY,  CA  94404 -1102
Applicant Contact ANDREW L BLATZ
Correspondent
AXON INSTRUMENTS, INC.
1101 CHESS DR.
FOSTER CITY,  CA  94404 -1102
Correspondent Contact ANDREW L BLATZ
Regulation Number882.1330
Classification Product Code
GZL  
Date Received03/14/1997
Decision Date 08/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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