K091380 is an FDA 510(k) clearance for the CORDCAP. This device is classified as a Cord, Retraction.
Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 30, 2009, 80 days after receiving the submission on May 11, 2009.
This device falls under the Dental FDA review panel.
| 510(k) Number | K091380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2009 |
| Decision Date | July 30, 2009 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MVL — Cord, Retraction |
| Device Class | — |