Submission Details
| 510(k) Number | K024289 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 2002 |
| Decision Date | May 02, 2003 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
May 2003
Decision
130d
Days
Class 2
Risk
About This 510(k) Submission
K024289 is an FDA 510(k) clearance for the BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on May 2, 2003, 130 days after receiving the submission on December 23, 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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