The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Disposable Lectroswitch, Model E2503.
Device ID | K781510 |
510k Number | K781510 |
Device Name: | DISPOSABLE LECTROSWITCH, MODEL E2503 |
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 | 1978-09-01 |
Decision Date | 1978-10-24 |