The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Monarch Iii Iol Delivery System, Monarch Iii C Cartridge, Monarch Iii Handpiece (h4).
| Device ID | K112977 |
| 510k Number | K112977 |
| Device Name: | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | ALCON RESEARCH, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Catherine Goble |
| Correspondent | Catherine Goble 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 | 2011-10-06 |
| Decision Date | 2012-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10380659777629 | K112977 | 000 |