The following data is part of a premarket notification filed by Covidien, Formerly Valleylab, A Division Of Tyco H with the FDA for Ligasure 5 Mm Maryland Jaw Sealer/divider One-step Sealing (lf 17xx).
| Device ID | K133338 |
| 510k Number | K133338 |
| Device Name: | LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 5920 Longbow Dr Boulder, CO 80301 |
| Contact | Donald Henton |
| Correspondent | Donald Henton COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 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 | 2013-10-30 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521181585 | K133338 | 000 |
| 20884521181578 | K133338 | 000 |
| 20884521181561 | K133338 | 000 |