The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Cryocare Surgical System.
Device ID | K003811 |
510k Number | K003811 |
Device Name: | CRYOCARE SURGICAL SYSTEM |
Classification | Unit, Cryosurgical, Accessories |
Applicant | ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
Contact | Vincent Cutarelli |
Correspondent | Vincent Cutarelli ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
Product Code | GEH |
CFR Regulation Number | 878.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-12-11 |
Decision Date | 2001-10-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRYOCARE SURGICAL SYSTEM 76140308 2753656 Dead/Cancelled |
Endocare, Inc. 2000-10-04 |