The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Lite Bio Delivery System.
| Device ID | K160978 |
| 510k Number | K160978 |
| Device Name: | LITe BIO Delivery System |
| Classification | Syringe, Piston |
| Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Meriam Gabera |
| Correspondent | Meriam Gabera STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-07 |
| Decision Date | 2016-07-08 |