K172203 is an FDA 510(k) clearance for the CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray. This device is classified as a Vapocoolant Device.
Submitted by Nuance Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on October 18, 2017, 89 days after receiving the submission on July 21, 2017.
This device falls under the Physical Medicine FDA review panel.
| 510(k) Number | K172203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2017 |
| Decision Date | October 18, 2017 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | MLY - Vapocoolant Device |
| Device Class | - |