The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Generator, Electrosurgical.
Device ID | K780206 |
510k Number | K780206 |
Device Name: | GENERATOR, ELECTROSURGICAL |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-02-07 |
Decision Date | 1978-02-21 |