Submission Details
| 510(k) Number | K023455 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 2002 |
| Decision Date | February 28, 2003 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
Feb 2003
Decision
136d
Days
Class 2
Risk
About This 510(k) Submission
K023455 is an FDA 510(k) clearance for the AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on February 28, 2003, 136 days after receiving the submission on October 15, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.
Device Classification
| Product Code | MRC — Products, Contact Lens Care, Rigid Gas Permeable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5918 |
Manufacturer
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