The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Modification To Cryocare Cs Surgical System.
| Device ID | K050347 |
| 510k Number | K050347 |
| Device Name: | MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ENDOCARE, INC. 201 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Eben Gordon |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEH |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | OCL |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-11 |
| Decision Date | 2005-02-25 |
| Summary: | summary |