The following data is part of a premarket notification filed by Medicel Ag with the FDA for Visian Nanopoint 2.0 Injector Model Lp604430.
| Device ID | K101134 |
| 510k Number | K101134 |
| Device Name: | VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | MEDICEL AG 1911 WALKER AVE Monrovia, CA 91016 |
| Contact | John Coggan |
| Correspondent | John Coggan MEDICEL AG 1911 WALKER AVE Monrovia, CA 91016 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-22 |
| Decision Date | 2010-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630055211941 | K101134 | 000 |
| 07630055211934 | K101134 | 000 |