The following data is part of a premarket notification filed by Valleylab,a Division Of Tyco Healthcare Group Lp with the FDA for Forcetriad Electrosurgical Generator; Ligasure Instruments.
Device ID | K070162 |
510k Number | K070162 |
Device Name: | FORCETRIAD ELECTROSURGICAL GENERATOR; LIGASURE INSTRUMENTS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB,A DIVISION OF TYCO HEALTHCARE GROUP LP 5920 LONGBOW DR. Boulder, CO 80301 |
Contact | Philip E Ake |
Correspondent | Philip E Ake 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 | 2007-01-17 |
Decision Date | 2007-03-06 |
Summary: | summary |