The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Coated Electrodes.
Device ID | K962044 |
510k Number | K962044 |
Device Name: | VALLEYLAB COATED ELECTRODES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
Contact | Herbert Vinson |
Correspondent | Herbert Vinson VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 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 | 1996-05-28 |
Decision Date | 1996-08-30 |
Summary: | summary |