The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Ligasure Precise Instrument Vessel Sealing System-model # Ls1200 & Sligaure Generator.
| Device ID | K010010 |
| 510k Number | K010010 |
| Device Name: | VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Julie Ross |
| Correspondent | Julie Ross VALLEYLAB, INC. 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 | 2001-01-02 |
| Decision Date | 2001-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524001460 | K010010 | 000 |