The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Davis Bayonet Electrodes.
Device ID | K964602 |
510k Number | K964602 |
Device Name: | DAVIS BAYONET ELECTRODES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
Contact | Herbert Vinson |
Correspondent | Herbert Vinson 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 | 1996-11-18 |
Decision Date | 1997-01-09 |
Summary: | summary |