The following data is part of a premarket notification filed by Orange Medical Instruments, Inc. with the FDA for Trends Lancet.
| Device ID | K843882 |
| 510k Number | K843882 |
| Device Name: | TRENDS LANCET |
| Classification | Device, Intravascular Catheter Securement |
| 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 | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-02 |
| Decision Date | 1984-11-05 |