The following data is part of a premarket notification filed by Cryopen, Inc. with the FDA for Cryopen Cryosurgical System, K102214.
| Device ID | K110754 |
| 510k Number | K110754 |
| Device Name: | CRYOPEN CRYOSURGICAL SYSTEM, K102214 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYOPEN, INC. 577 COMMERCE ST SUITE B Southlake, TX 76092 |
| Contact | Mike Haas, M.d. |
| Correspondent | Mike Haas, M.d. CRYOPEN, INC. 577 COMMERCE ST SUITE B Southlake, TX 76092 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-18 |
| Decision Date | 2011-09-09 |
| Summary: | summary |