The following data is part of a premarket notification filed by Semantodontics, Inc. with the FDA for 3mm Disposable Specula.
| Device ID | K891589 |
| 510k Number | K891589 |
| Device Name: | 3MM DISPOSABLE SPECULA |
| Classification | Specula Accessories |
| Applicant | SEMANTODONTICS, INC. 3400 EAST MCDOWELL RD. PHOENIX, AZ 85008 |
| Contact | DANIEL F ENRIQUEZ |
| Correspondent | DANIEL F ENRIQUEZ SEMANTODONTICS, INC. 3400 EAST MCDOWELL RD. PHOENIX, AZ 85008 |
| Product Code | FXG |
| CFR Regulation Number | 878.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-04-18 |