The following data is part of a premarket notification filed by Valleylab with the FDA for Ligasure Advance Laparoscopic Sealer/divider With Dissecting Electrode, Models Lf5034 And Lf5044.
| Device ID | K063195 |
| 510k Number | K063195 |
| Device Name: | LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Charles Copperberg |
| Correspondent | Charles Copperberg VALLEYLAB 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 | 2006-10-20 |
| Decision Date | 2006-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884524002273 | K063195 | 000 |