The following data is part of a premarket notification filed by Orange Medical Instruments, Inc. with the FDA for Micro-beta U100 Syringe.
| Device ID | K844796 |
| 510k Number | K844796 |
| Device Name: | MICRO-BETA U100 SYRINGE |
| Classification | Syringe, Piston |
| Applicant | ORANGE MEDICAL INSTRUMENTS, INC. 3183 AIRWAY AVE. SUITE F Costa Mesa, CA 92626 |
| Contact | Helene Ehrlich |
| Correspondent | Helene Ehrlich ORANGE MEDICAL INSTRUMENTS, INC. 3183 AIRWAY AVE. SUITE F Costa Mesa, CA 92626 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-11 |
| Decision Date | 1984-12-18 |