Luhr Micro Mesh
FDA 510(k) K901940 · Howmedica Corp.
510(k) numberK901940
Submission
- Device name
- Luhr Micro Mesh
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- April 30, 1990
- Decision date
- September 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Luhr Micro Mesh cleared by the FDA?
Luhr Micro Mesh (K901940) received a 510(k) decision of Substantially Equivalent on September 6, 1990, 129 days after the submission was received.
What is the product code of K901940?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.