The following data is part of a premarket notification filed by West Pharmaceutical Services, Inc. with the FDA for Novaguard, Model 3611001.
| Device ID | K082908 |
| 510k Number | K082908 |
| Device Name: | NOVAGUARD, MODEL 3611001 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WEST PHARMACEUTICAL SERVICES, INC. 101 GORDON DR. Lionville, PA 19341 |
| Contact | Ari Y Sobel |
| Correspondent | Ari Y Sobel WEST PHARMACEUTICAL SERVICES, INC. 101 GORDON DR. Lionville, PA 19341 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2009-04-24 |
| Summary: | summary |