The following data is part of a premarket notification filed by Teledyne Densco with the FDA for Prophylaxis Cup..
| Device ID | K803155 |
| 510k Number | K803155 |
| Device Name: | PROPHYLAXIS CUP. |
| Classification | Cup, Prophylaxis |
| Applicant | TELEDYNE DENSCO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHK |
| CFR Regulation Number | 872.6290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-12 |
| Decision Date | 1981-01-08 |