The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab E2750 Laparoscopic Handset, Valleylab E2770 Series Electrodes.
| Device ID | K964175 |
| 510k Number | K964175 |
| Device Name: | VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Contact | Pegy Walline |
| Correspondent | Pegy 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 | 1996-10-18 |
| Decision Date | 1996-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884524000545 | K964175 | 000 |
| 30884524000408 | K964175 | 000 |