The following data is part of a premarket notification filed by Ast Products, Inc. with the FDA for Bioli Lol Delivery System.
| Device ID | K200057 |
| 510k Number | K200057 |
| Device Name: | Bioli LOL Delivery System |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 |
| Contact | William Lee |
| Correspondent | William Lee AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-13 |
| Decision Date | 2020-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814899027136 | K200057 | 000 |
| 00814899027129 | K200057 | 000 |
| 00814899027075 | K200057 | 000 |
| 00814899027167 | K200057 | 000 |