The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Force Gsu System W/ Laparoscopic Option.
Device ID | K922090 |
510k Number | K922090 |
Device Name: | FORCE GSU SYSTEM W/ LAPAROSCOPIC OPTION |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Contact | Peggy Walline |
Correspondent | Peggy Walline 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 | 1992-05-05 |
Decision Date | 1992-08-04 |