K070669 is an FDA 510(k) clearance for the IOL INJECTOR SET. This device is classified as a Lens, Guide, Intraocular (Class I - General Controls, product code KYB).
Submitted by Medicel AG (Hasbrouck Heights, US). The FDA issued a Cleared decision on November 1, 2007, 234 days after receiving the submission on March 12, 2007.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K070669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2007 |
| Decision Date | November 01, 2007 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | KYB - Lens, Guide, Intraocular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4300 |