The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab #e2751 & E2780r Laparoscopic Handpiece.
Device ID | K925647 |
510k Number | K925647 |
Device Name: | VALLEYLAB #E2751 & E2780R LAPAROSCOPIC HANDPIECE |
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 | 1992-11-09 |
Decision Date | 1993-09-29 |