The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Models E2502b/e2525 Reusable Handswitching Pencils.
Device ID | K914400 |
510k Number | K914400 |
Device Name: | MODELS E2502B/E2525 REUSABLE HANDSWITCHING PENCILS |
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 | 1991-10-02 |
Decision Date | 1991-10-17 |