The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Monarch Iol Delivery System.
| Device ID | K981571 |
| 510k Number | K981571 |
| Device Name: | MONARCH IOL DELIVERY SYSTEM |
| Classification | Lens, Guide, Intraocular |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Contact | Martin A Kaufman |
| Correspondent | Martin A Kaufman ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-04 |
| Decision Date | 1998-07-09 |
| Summary: | summary |