The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E1070 & E1080 Series Reusable Lletz Electrodes.
| Device ID | K921885 |
| 510k Number | K921885 |
| Device Name: | E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES |
| Classification | Heater, Perineal, Direct Contact |
| 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 | HGZ |
| CFR Regulation Number | 884.5390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-21 |
| Decision Date | 1994-03-25 |