K033194 is an FDA 510(k) clearance for the INION CPS BABY 1.5 BIOABSORBABLE SYSTEM. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on October 30, 2003, 28 days after receiving the submission on October 2, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K033194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2003 |
| Decision Date | October 30, 2003 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |