Myerson/Kenson GP Polymer
FDA 510(k) K813328 · Howmedica Corp.
510(k) numberK813328
Submission
- Device name
- Myerson/Kenson GP Polymer
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- November 24, 1981
- Decision date
- February 24, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Myerson/Kenson GP Polymer cleared by the FDA?
Myerson/Kenson GP Polymer (K813328) received a 510(k) decision of Substantially Equivalent on February 24, 1982, 92 days after the submission was received.
What is the product code of K813328?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.