The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for The Placer.
| Device ID | K811582 |
| 510k Number | K811582 |
| Device Name: | THE PLACER |
| Classification | Syringe, Restorative And Impression Material |
| Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EID |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-05 |
| Decision Date | 1981-07-28 |