K032910 is an FDA 510(k) clearance for the CARRIAZO PENDULAR. This device is classified as a Keratome, Ac-powered (Class I - General Controls, product code HNO).
Submitted by Schwind Eye-Tech-Solutions GmbH & Co. KG (Coto De Caza, US). The FDA issued a Cleared decision on August 30, 2004, 343 days after receiving the submission on September 22, 2003.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.
| 510(k) Number | K032910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2003 |
| Decision Date | August 30, 2004 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HNO — Keratome, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4370 |