The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Model Ta-cs10 Spectraject Control Syringe.
| Device ID | K880740 |
| 510k Number | K880740 |
| Device Name: | MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE |
| Classification | Actuator, Syringe, Injector Type |
| Applicant | SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Robert L Leavitt |
| Correspondent | Robert L Leavitt SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Product Code | DQF |
| CFR Regulation Number | 870.1670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-24 |
| Decision Date | 1988-03-22 |