The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Amo Prestige Day Pack (allergan, Inc.).
| Device ID | K962402 |
| 510k Number | K962402 |
| Device Name: | AMO PRESTIGE DAY PACK (ALLERGAN, INC.) |
| Classification | Unit, Phacofragmentation |
| Applicant | ALLERGAN, INC. 2525 DUPONT DR. Irvine, CA 92612 |
| Contact | Monique M Heyninck |
| Correspondent | Monique M Heyninck ALLERGAN, INC. 2525 DUPONT DR. Irvine, CA 92612 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-21 |
| Decision Date | 1996-09-19 |
| Summary: | summary |