The following data is part of a premarket notification filed by West Pharmaceutical Services, Inc. with the FDA for Novaguard Sa Pro Safety System.
| Device ID | K163511 |
| 510k Number | K163511 |
| Device Name: | NovaGuard SA Pro Safety System |
| Classification | Syringe, Antistick |
| Applicant | WEST PHARMACEUTICAL SERVICES, INC. 530 HERMAN O. WEST DRIVE Exton, PA 19341 -1147 |
| Contact | Ana Ladino |
| Correspondent | Ana Ladino WEST PHARMACEUTICAL SERVICES, INC. 530 HERMAN O. WEST DRIVE Exton, PA 19341 -1147 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-15 |
| Decision Date | 2017-02-02 |
| Summary: | summary |