Chempad(Tm), Electroconductive Media (882.1275)
FDA 510(k) K901630 · Henley Intl.
510(k) numberK901630
Submission
- Device name
- Chempad(Tm), Electroconductive Media (882.1275)
- Applicant
- Henley Intl.
Sugar Land, TX, US - Received
- April 9, 1990
- Decision date
- July 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Chempad(Tm), Electroconductive Media (882.1275) cleared by the FDA?
Chempad(Tm), Electroconductive Media (882.1275) (K901630) received a 510(k) decision of Substantially Equivalent on July 16, 1990, 98 days after the submission was received.
What is the product code of K901630?
The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.