The following data is part of a premarket notification filed by Salvin Dental Specialties with the FDA for Cytosurg Non-resorbable Ptfe Membrane, 25mm X 30mm, Cytosurg Non-resorbable Ptfe Membrane, 12mm X 24mm.
| Device ID | K160493 |
| 510k Number | K160493 |
| Device Name: | Cytosurg Non-resorbable PTFE Membrane, 25mm X 30mm, Cytosurg Non-resorbable PTFE Membrane, 12mm X 24mm |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | Salvin Dental Specialties 3450 Latrobe Drive Charlotte, NC 28211 |
| Contact | Jennifer Singer |
| Correspondent | John Kapitan Kapstone Medical 100 E. South Main St., PO Box 1458 Waxhaw, NC 28173 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-22 |
| Decision Date | 2016-09-08 |
| Summary: | summary |