The following data is part of a premarket notification filed by Valleylab with the FDA for Ligasure Precise Model #ls1200/ligasure 5mm Laparoscopic Sealer Divider Model # Ls1500.
Device ID | K041587 |
510k Number | K041587 |
Device Name: | LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 |
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 | 2004-06-14 |
Decision Date | 2004-09-28 |
Summary: | summary |