The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Macrobipolar Forceps Handpiece, E3200.
| Device ID | K926414 |
| 510k Number | K926414 |
| Device Name: | VALLEYLAB MACROBIPOLAR FORCEPS HANDPIECE, E3200 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Peggy Willine |
| Correspondent | Peggy Willine 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 | 1992-12-23 |
| Decision Date | 1993-05-17 |