Electroconductive Media
FDA 510(k) K904377 · Henley Intl.
510(k) numberK904377
Submission
- Device name
- Electroconductive Media
- Applicant
- Henley Intl.
Sugar Land, TX, US - Received
- September 24, 1990
- Decision date
- November 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Electroconductive Media cleared by the FDA?
Electroconductive Media (K904377) received a 510(k) decision of Substantially Equivalent on November 15, 1991, 417 days after the submission was received.
What is the product code of K904377?
The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.