The following data is part of a premarket notification filed by Injectimed, Inc. with the FDA for Protector Syringe Safety Cap System.
| Device ID | K922158 |
| 510k Number | K922158 |
| Device Name: | PROTECTOR SYRINGE SAFETY CAP SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | INJECTIMED, INC. WEST 2737 PALMA DR. Ventura, CA 93003 |
| Contact | Thomas C Kuracina |
| Correspondent | Thomas C Kuracina INJECTIMED, INC. WEST 2737 PALMA DR. Ventura, CA 93003 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-07 |
| Decision Date | 1992-07-21 |