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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K003924
Device Name MAVIDON MEDICAL ELECTRODE JELLY
Applicant
MAVIDON MEDICAL PRODUCTS
2105 7TH AVE. NO.
LAKE WORTH,  FL  33461
Applicant Contact TIM CARROLL
Correspondent
MAVIDON MEDICAL PRODUCTS
2105 7TH AVE. NO.
LAKE WORTH,  FL  33461
Correspondent Contact TIM CARROLL
Regulation Number882.1275
Classification Product Code
GYB  
Date Received12/20/2000
Decision Date 08/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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