The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E3590, Smoke Evacuation Attchment For Electrosurgical Pencils.
Device ID | K945260 |
510k Number | K945260 |
Device Name: | E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
Contact | Peggy Walline |
Correspondent | Peggy Walline 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 | 1994-10-28 |
Decision Date | 1994-11-09 |