The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Mojave Cataract Extraction System.
| Device ID | K003638 |
| 510k Number | K003638 |
| Device Name: | MOJAVE CATARACT EXTRACTION SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
| Contact | Mark O'donnell |
| Correspondent | Mark O'donnell ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-24 |
| Decision Date | 2001-02-13 |