The following data is part of a premarket notification filed by Valleylab,a Division Of Tyco Healthcare Group Lp with the FDA for Cool-tip Switching Controller, Ctsw Control.
| Device ID | K070446 |
| 510k Number | K070446 |
| Device Name: | COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB,A DIVISION OF TYCO HEALTHCARE GROUP LP 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Julie Ross |
| Correspondent | Julie Ross VALLEYLAB,A DIVISION OF TYCO HEALTHCARE GROUP LP 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-15 |
| Decision Date | 2007-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524002798 | K070446 | 000 |
| 10884521165779 | K070446 | 000 |