The following data is part of a premarket notification filed by Nuance Medical, Llc with the FDA for Nuance Cryo-freeze Spray Or Cryo-in-a-can Or Vandolay Freeze Spray.
| Device ID | K130995 |
| 510k Number | K130995 |
| Device Name: | NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | NUANCE MEDICAL, LLC 300 CARLSBAD VILLAGE DRIVE, SUITE 108 Carlsbad, CA 92008 |
| Contact | Marc S Lieberman |
| Correspondent | Marc S Lieberman NUANCE MEDICAL, LLC 300 CARLSBAD VILLAGE DRIVE, SUITE 108 Carlsbad, CA 92008 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-10 |
| Decision Date | 2013-06-14 |
| Summary: | summary |