The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Model Opo-32 Irrigation Sleeve.
| Device ID | K874543 |
| 510k Number | K874543 |
| Device Name: | MODEL OPO-32 IRRIGATION SLEEVE |
| Classification | Syringe, Irrigating (dental) |
| Applicant | ALLERGAN, INC. POST OFFICE BOX 25155 Santa Ana, CA 92799 |
| Contact | Paul S Kramsky |
| Correspondent | Paul S Kramsky ALLERGAN, INC. POST OFFICE BOX 25155 Santa Ana, CA 92799 |
| Product Code | EIB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-03 |
| Decision Date | 1988-01-14 |