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510(k) K003924

MAVIDON MEDICAL ELECTRODE JELLY by Mavidon Medical Products — Product Code GYB

K003924 is an FDA 510(k) premarket notification submitted by Mavidon Medical Products for the device "MAVIDON MEDICAL ELECTRODE JELLY". The FDA issued a decision of Substantially Equivalent on August 24, 2001. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2001
Date Received
December 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

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FDA data resources