The following data is part of a premarket notification filed by Ast Products, Inc. with the FDA for Lioli Iol Delivery System.
| Device ID | K142056 |
| 510k Number | K142056 |
| Device Name: | LIOLI IOL DELIVERY SYSTEM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | AST PRODUCTS, INC. 9 Linnell Circle Billerica, MA 01821 |
| Contact | William Lee |
| Correspondent | David Lim REGULATORY DOCTOR 3955 RINER ROAD, BOX148 Riner, VA 24149 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-29 |
| Decision Date | 2015-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814899027027 | K142056 | 000 |
| 10814899027010 | K142056 | 000 |
| 10814899027003 | K142056 | 000 |