The following data is part of a premarket notification filed by Nuance Medical, Llc with the FDA for Cryodose H Or Similar.
| Device ID | K161337 |
| 510k Number | K161337 |
| Device Name: | CryoDose H Or Similar |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | NUANCE MEDICAL, LLC 5931 Sea Lion Place, Suite 113 Carlsbad, CA 92008 |
| Contact | Marc Lieberman |
| Correspondent | Marc Lieberman NUANCE MEDICAL, LLC 5931 Sea Lion Place, Suite 113 Carlsbad, CA 92010 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-13 |
| Decision Date | 2016-07-12 |
| Summary: | summary |