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 |