The following data is part of a premarket notification filed by 3jt Enterprises Llc with the FDA for Cryonize Tm.
| Device ID | K103310 |
| 510k Number | K103310 |
| Device Name: | CRYONIZE TM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | 3JT ENTERPRISES LLC 2000 N. RACINE AVE SUITE 3100 Chicago, IL 60614 |
| Contact | Anthony Goldboss |
| Correspondent | Anthony Goldboss 3JT ENTERPRISES LLC 2000 N. RACINE AVE SUITE 3100 Chicago, IL 60614 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-10 |
| Decision Date | 2011-02-09 |
| Summary: | summary |