The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Unitek Disposable Impression Syringe.
| Device ID | K851386 |
| 510k Number | K851386 |
| Device Name: | UNITEK DISPOSABLE IMPRESSION SYRINGE |
| Classification | Syringe, Restorative And Impression Material |
| Applicant | UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Contact | Lawrence Stevens |
| Correspondent | Lawrence Stevens UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Product Code | EID |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-09 |
| Decision Date | 1985-04-29 |