Nanor and Efficast/Nanor Hybrid Thermoplastic Materials
FDA 510(k) K131795 · Orfit Industries NV
510(k) numberK131795
Submission
- Device name
- Nanor and Efficast/Nanor Hybrid Thermoplastic Materials
- Applicant
- Orfit Industries NV
Wijnegem, BE - Received
- June 18, 2013
- Decision date
- September 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Nanor and Efficast/Nanor Hybrid Thermoplastic Materials cleared by the FDA?
Nanor and Efficast/Nanor Hybrid Thermoplastic Materials (K131795) received a 510(k) decision of Substantially Equivalent on September 26, 2013, 100 days after the submission was received.
What is the product code of K131795?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.