The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Sovereign Cataract Extraction System.
| Device ID | K981116 |
| 510k Number | K981116 |
| Device Name: | SOVEREIGN CATARACT EXTRACTION SYSTEM |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
| Contact | Marcia S Yaross, Ph,d. |
| Correspondent | Marcia S Yaross, Ph,d. ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-27 |
| Decision Date | 1998-05-19 |
| Summary: | summary |