The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon Series 20000 Legacy Mackool System.
| Device ID | K955789 |
| 510k Number | K955789 |
| Device Name: | ALCON SERIES 20000 LEGACY MACKOOL SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | ALCON LABORATORIES 6201 S FREEWAY Ft Worth, TX 76134 |
| Contact | Martin A Kaufman |
| Correspondent | Martin A Kaufman ALCON LABORATORIES 6201 S FREEWAY Ft Worth, TX 76134 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1996-03-21 |
| Summary: | summary |