The following data is part of a premarket notification filed by Alcon Surgical, Inc. with the FDA for Automated Hydrosonics(tm).
| Device ID | K902798 |
| 510k Number | K902798 |
| Device Name: | AUTOMATED HYDROSONICS(TM) |
| Classification | Unit, Phacofragmentation |
| Applicant | ALCON SURGICAL, INC. 17701 COWAN AVE. Irvine, CA 92713 |
| Contact | David Krapf |
| Correspondent | David Krapf ALCON SURGICAL, INC. 17701 COWAN AVE. Irvine, CA 92713 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-27 |
| Decision Date | 1990-08-28 |