The following data is part of a premarket notification filed by Alcon Manufacturing, Ltd. with the FDA for Monarch Iii Iol Delivery System.
| Device ID | K063155 |
| 510k Number | K063155 |
| Device Name: | MONARCH III IOL DELIVERY SYSTEM |
| Classification | Lens, Guide, Intraocular |
| Applicant | ALCON MANUFACTURING, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Catherine G Goble |
| Correspondent | Catherine G Goble ALCON MANUFACTURING, LTD. 6201 SOUTH FREEWAY 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 | 2006-10-17 |
| Decision Date | 2007-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10380659777636 | K063155 | 000 |