The following data is part of a premarket notification filed by Neoss Ltd with the FDA for Neoss Ti Reinforced Membrane.
| Device ID | K143327 |
| 510k Number | K143327 |
| Device Name: | Neoss Ti Reinforced Membrane |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | Neoss Ltd Windsor House Cornwall Road Harrogate, GB Hg1 2pw |
| Contact | Karin Darle Olsson |
| Correspondent | Cherita James M Sqaured Associates, Inc. 575 8th Avenue, Suite 1212 New York, NY 10018 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-20 |
| Decision Date | 2015-04-13 |
| Summary: | summary |