K003646 is an FDA 510(k) clearance for the SUTUREGROOVE WEIGHT SIZING SET. 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 February 22, 2001, 87 days after receiving the submission on November 27, 2000.
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 | K003646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 27, 2000 |
| Decision Date | February 22, 2001 |
| Days to Decision | 87 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) |