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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K040639
Device Name ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE
Applicant
ISURGICAL
26625 COUNTRYSIDE LAKE DRIVE
MUNDELEIN,  IL  60060
Applicant Contact KEN LEISER
Correspondent
ISURGICAL
26625 COUNTRYSIDE LAKE DRIVE
MUNDELEIN,  IL  60060
Correspondent Contact KEN LEISER
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received03/10/2004
Decision Date 05/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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