The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Namic Rcs Syringe.
| Device ID | K140194 |
| 510k Number | K140194 |
| Device Name: | NAMIC RCS SYRINGE |
| Classification | Syringe, Piston |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Brandon M Brackett |
| Correspondent | Brandon M Brackett NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-27 |
| Decision Date | 2014-04-14 |
| Summary: | summary |