K994289 is an FDA 510(k) clearance for the SUTUREGROOVE. This device is classified as a Weights, Eyelid, External (Class II - Special Controls, product code MML).
Submitted by Iop, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on April 17, 2000, 118 days after receiving the submission on December 21, 1999.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5700. Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure).
| 510(k) Number | K994289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1999 |
| Decision Date | April 17, 2000 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | MML — Weights, Eyelid, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5700 |
| Definition | Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure) |