The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Model E2517 And Model E2503 Power Control Pencils.
Device ID | K861112 |
510k Number | K861112 |
Device Name: | MODEL E2517 AND MODEL E2503 POWER CONTROL 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 | 1986-03-25 |
Decision Date | 1986-05-20 |