K071218 is an FDA 510(k) clearance for the PROXENON 350, MODEL 902XX. This device is classified as a Light, Surgical, Fiberoptic (Class II - Special Controls, product code FST).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on June 14, 2007, 43 days after receiving the submission on May 2, 2007.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K071218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2007 |
| Decision Date | June 14, 2007 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FST — Light, Surgical, Fiberoptic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |