The following data is part of a premarket notification filed by River Medical, Inc. with the FDA for River Vial Adapter.
| Device ID | K933335 |
| 510k Number | K933335 |
| Device Name: | RIVER VIAL ADAPTER |
| Classification | Syringe, Piston |
| Applicant | RIVER MEDICAL, INC. 5893 OBERLIN DR. SUITE 106 San Diego, CA 92121 |
| Contact | Jim C Caputo |
| Correspondent | Jim C Caputo RIVER MEDICAL, INC. 5893 OBERLIN DR. SUITE 106 San Diego, CA 92121 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-08 |
| Decision Date | 1994-03-01 |