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 |