K983150 is an FDA 510(k) clearance for the COMPLETE BRAND 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 November 25, 1998, 77 days after receiving the submission on September 9, 1998.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K983150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1998 |
| Decision Date | November 25, 1998 |
| Days to Decision | 77 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 |