The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Model E2515 Electrosurgical Accessory.
| Device ID | K791639 |
| 510k Number | K791639 |
| Device Name: | MODEL E2515 ELECTROSURGICAL ACCESSORY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-21 |
| Decision Date | 1979-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524001613 | K791639 | 000 |
| 10884524001845 | K791639 | 000 |
| 30884524000446 | K791639 | 000 |