The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Model E2510 Surgiswitch.
Device ID | K791638 |
510k Number | K791638 |
Device Name: | MODEL E2510 SURGISWITCH |
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 | 1979-08-21 |
Decision Date | 1979-09-12 |