The following data is part of a premarket notification filed by Allergan Medical Optics with the FDA for Amo(r) Flrx-tip(tm) Dispos I/a Handpiece, Opo-38.
| Device ID | K925254 |
| 510k Number | K925254 |
| Device Name: | AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 |
| Classification | Unit, Phacofragmentation |
| Applicant | ALLERGAN MEDICAL OPTICS KM 4,2 RD. 402 Anasco, PR 00610 |
| Contact | Barbara A Niksch |
| Correspondent | Barbara A Niksch ALLERGAN MEDICAL OPTICS KM 4,2 RD. 402 Anasco, PR 00610 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-19 |
| Decision Date | 1993-01-07 |