CRYOCARE SURGICAL SYSTEM
Unit, Cryosurgical, Accessories
ENDOCARE, INC.
The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Cryocare Surgical System.
Pre-market Notification Details
| Device ID | K011074 |
| 510k Number | K011074 |
| Device Name: | CRYOCARE SURGICAL SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
| Contact | Vincent Cutartelli |
| Correspondent | Vincent Cutartelli 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 | 2001-04-09 |
| Decision Date | 2002-01-25 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810563020106 | K011074 | 000 |
| 00810563020960 | K011074 | 000 |
| 00810563020953 | K011074 | 000 |
Trademark Results [CRYOCARE SURGICAL SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRYOCARE SURGICAL SYSTEM 76140308 2753656 Dead/Cancelled |
Endocare, Inc. 2000-10-04 |
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