The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Monarch Iol Delivery System.
| Device ID | K970033 |
| 510k Number | K970033 |
| Device Name: | MONARCH IOL DELIVERY SYSTEM |
| Classification | Lens, Guide, Intraocular |
| 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 | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-03 |
| Decision Date | 1997-04-23 |
| Summary: | summary |