The following data is part of a premarket notification filed by Nuance Medical, Llc with the FDA for Cryodose Ta Otc, Mist Spray, Cryodose Ta Otc, Stream Spray.
| Device ID | K172203 |
| 510k Number | K172203 |
| Device Name: | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | Nuance Medical, LLC 5931 Sea Lion Place, Suite 113 Carlsbad, CA 92010 |
| Contact | Marc Lieberman |
| Correspondent | Marc Lieberman Nuance Medical, LLC 5931 Sea Lion Place, Suite 113 Carlsbad, CA 92010 |
| Product Code | MLY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-21 |
| Decision Date | 2017-10-18 |
| Summary: | summary |