The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Cryocare Surgical System, Model Cryo 20.
| Device ID | K023757 |
| 510k Number | K023757 |
| Device Name: | CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ENDOCARE, INC. 201 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon 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 | 2002-11-08 |
| Decision Date | 2002-12-05 |
| Summary: | summary |