The following data is part of a premarket notification filed by Tribofilm Research, Inc. with the FDA for Triboglide Lubricated Silicone-free Syringe.
| Device ID | K071027 |
| 510k Number | K071027 |
| Device Name: | TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE |
| Classification | Syringe, Piston |
| Applicant | TRIBOFILM RESEARCH, INC. 625 HUTTON STREET SUITE 105 Raleigh, NC 27606 |
| Contact | Vinay Sakhrani |
| Correspondent | Vinay Sakhrani TRIBOFILM RESEARCH, INC. 625 HUTTON STREET SUITE 105 Raleigh, NC 27606 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-11 |
| Decision Date | 2007-07-20 |
| Summary: | summary |