K012917 is an FDA 510(k) clearance for the DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B. This device is classified as a Clamp, Umbilical (Class II - Special Controls, product code HFW).
Submitted by Dynarex Corp. (Mainville, US). The FDA issued a Cleared decision on November 28, 2001, 90 days after receiving the submission on August 30, 2001.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K012917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2001 |
| Decision Date | November 28, 2001 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFW — Clamp, Umbilical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |