The following data is part of a premarket notification filed by Medicel Ag with the FDA for Naviject Sub2-1p, Model: Lp604430.
| Device ID | K092023 |
| 510k Number | K092023 |
| Device Name: | NAVIJECT SUB2-1P, MODEL: LP604430 |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | MEDICEL AG 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers MEDICEL AG 377 ROUTE 17 S Hasbrouck Heights, NJ 07604 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630055213976 | K092023 | 000 |
| 07630055211897 | K092023 | 000 |