The following data is part of a premarket notification filed by Abbott Medical Optics Inc with the FDA for Amo Brand Multi-purpose Disinfecting Solution.
| Device ID | K093254 |
| 510k Number | K093254 |
| Device Name: | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION |
| Classification | Accessories, Soft Lens Products |
| Applicant | ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE Santa Ana, CA 92705 |
| Contact | Kesley E Gallagher |
| Correspondent | Kesley E Gallagher ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE Santa Ana, CA 92705 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-16 |
| Decision Date | 2010-09-15 |
| Summary: | summary |