K992028 is an FDA 510(k) clearance for the REFRESH CONTACTS LUBRICATING AND REWETTING DROPS. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).
Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on October 7, 1999, 113 days after receiving the submission on June 16, 1999.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K992028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 1999 |
| Decision Date | October 07, 1999 |
| Days to Decision | 113 days |
| Submission Type | Abbreviated |
| 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 |