The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Endocare Crycare Cryosurgical System.
| Device ID | K963826 |
| 510k Number | K963826 |
| Device Name: | ENDOCARE CRYCARE CRYOSURGICAL SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ENDOCARE, INC. 18 TECHNOLOGY DR., SUITE 134 Irvine, CA 92718 |
| Contact | Vin Cutarelli |
| Correspondent | Vin Cutarelli ENDOCARE, INC. 18 TECHNOLOGY DR., SUITE 134 Irvine, CA 92718 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-25 |
| Decision Date | 1996-12-18 |
| Summary: | summary |