The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Monarch Ii Iol Delivery System.
| Device ID | K003768 |
| 510k Number | K003768 |
| Device Name: | MONARCH II IOL DELIVERY SYSTEM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Sherri J Lakota |
| Correspondent | Sherri J Lakota ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-06 |
| Decision Date | 2001-01-05 |