The following data is part of a premarket notification filed by Medicel Ag with the FDA for Multiject Injector And Microglide Cartridge.
| Device ID | K040837 |
| 510k Number | K040837 |
| Device Name: | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-31 |
| Decision Date | 2004-06-17 |
| Summary: | summary |