The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Laparoscopic Handswitch/electrodes.
| Device ID | K904560 |
| 510k Number | K904560 |
| Device Name: | VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Mark Wenzel |
| Correspondent | Mark Wenzel 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 | 1990-10-05 |
| Decision Date | 1990-12-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524002009 | K904560 | 000 |
| 20884524000555 | K904560 | 000 |
| 20884524000562 | K904560 | 000 |
| 20884524000579 | K904560 | 000 |
| 30884524000583 | K904560 | 000 |
| 30884524001948 | K904560 | 000 |
| 30884524001955 | K904560 | 000 |
| 30884524001962 | K904560 | 000 |
| 30884524001979 | K904560 | 000 |
| 20884524001989 | K904560 | 000 |
| 30884524001993 | K904560 | 000 |
| 20884524000432 | K904560 | 000 |