The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Cryocare Cs Surgical System.
| Device ID | K101333 |
| 510k Number | K101333 |
| Device Name: | CRYOCARE CS SURGICAL SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ENDOCARE, INC. 9825 SPECTRUM DRIVE BLDG 2 Austin, TX 78717 |
| Contact | Devonne Pavlak |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-12 |
| Decision Date | 2010-06-14 |
| Summary: | summary |