The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Cryocare Cn2 System.
| Device ID | K062175 |
| 510k Number | K062175 |
| Device Name: | CRYOCARE CN2 SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ENDOCARE, INC. 201 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Alden Kay |
| Correspondent | Alden Kay ENDOCARE, INC. 201 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-31 |
| Decision Date | 2006-08-28 |
| Summary: | summary |