The following data is part of a premarket notification filed by Asico Llc with the FDA for Royale Ae 9036 Lsp Injector.
| Device ID | K073010 |
| 510k Number | K073010 |
| Device Name: | ROYALE AE 9036 LSP INJECTOR |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | ASICO LLC 26 PLAZA DR. Westmont, IL 60559 |
| Contact | Ravi Nallakrishnan |
| Correspondent | Silvia Ankova UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-10-25 |
| Decision Date | 2007-11-07 |
| Summary: | summary |