K033656 is an FDA 510(k) clearance for the SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE. This device is classified as a Case, Contact Lens (Class II - Special Controls, product code LRX).
Submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on February 2, 2004, 73 days after receiving the submission on November 21, 2003.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K033656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2003 |
| Decision Date | February 02, 2004 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LRX — Case, Contact Lens |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |