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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 K041409
Device Name MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
Applicant
INOMED GMBH
KUNGSTENSGATAN 18, PO BX 7593
SE-103 93 STOCKHOLM,  SE
Applicant Contact ANDERS SKOGLUND
Correspondent
INOMED GMBH
KUNGSTENSGATAN 18, PO BX 7593
SE-103 93 STOCKHOLM,  SE
Correspondent Contact ANDERS SKOGLUND
Regulation Number882.1330
Classification Product Code
GZL  
Date Received05/27/2004
Decision Date 08/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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