The following data is part of a premarket notification filed by Nuance Medical, Llc with the FDA for Cryodose V 50/50, 175ml Canister Kit, Cryodose V 50/50, 236ml Canister Kit.
| Device ID | K210310 |
| 510k Number | K210310 |
| Device Name: | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Nuance Medical, LLC 5931 Sea Lion Place, Suite 113 Carlsbad, CA 82010 |
| Contact | Neal Hartman |
| Correspondent | Neal Hartman Nuance Medical, LLC 5931 Sea Lion Place, Suite 113 Carlsbad, CA 82010 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-03 |
| Decision Date | 2021-10-22 |