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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 K830601
Device Name FOAMIES DIAPOS. FOAM RUBBER PADS
Applicant
Precision Cap Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Precision Cap Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/24/1983
Decision Date 03/24/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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