K202782 is an FDA 510(k) clearance for the num Vapocoolant. This device is classified as a Vapocoolant Device.
Submitted by 623 Medical, LLC (Morrisville, US). The FDA issued a Cleared decision on December 21, 2020, 90 days after receiving the submission on September 22, 2020.
This device falls under the Physical Medicine FDA review panel.
| 510(k) Number | K202782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2020 |
| Decision Date | December 21, 2020 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | MLY - Vapocoolant Device |
| Device Class | - |