K980591 is an FDA 510(k) clearance for the RENU MULTIPLUS LUBRICATING & REWETTING DROPS. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).
Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on June 24, 1998, 127 days after receiving the submission on February 17, 1998.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K980591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1998 |
| Decision Date | June 24, 1998 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPN - Accessories, Soft Lens Products |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |