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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K023212
Device Name AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS
Applicant
Ag Garments
1762 Columbia St.
San Diego,  CA  92101
Applicant Contact ATHENA SHUDDE
Correspondent
Ag Garments
1762 Columbia St.
San Diego,  CA  92101
Correspondent Contact ATHENA SHUDDE
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/26/2002
Decision Date 12/13/2002
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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