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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
Predetermined Change
Control Plan Authorized		 No
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