The following data is part of a premarket notification filed by Cimex Biotech, Llc. with the FDA for Cryopen And Accessories.
| Device ID | K012214 |
| 510k Number | K012214 |
| Device Name: | CRYOPEN AND ACCESSORIES |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CIMEX BIOTECH, LLC. 72385 INDUSTRY PARK Covington, LA 70435 |
| Contact | Michael Haas |
| Correspondent | Michael Haas CIMEX BIOTECH, LLC. 72385 INDUSTRY PARK Covington, LA 70435 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2002-04-26 |
| Summary: | summary |