The following data is part of a premarket notification filed by Sis Ltd. Surgical Instrument Systems with the FDA for Xact Lens Inserter System, Models 6mm, 7mm.
| Device ID | K082871 |
| 510k Number | K082871 |
| Device Name: | XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | SIS LTD. SURGICAL INSTRUMENT SYSTEMS 5401 COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SIS LTD. SURGICAL INSTRUMENT SYSTEMS 5401 COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2009-07-09 |
| Summary: | summary |