The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for E7509 Polyhesive Ii Patient Return Electrode.
| Device ID | K861036 |
| 510k Number | K861036 |
| Device Name: | E7509 POLYHESIVE II PATIENT RETURN ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524001791 | K861036 | 000 |
| 10884524001807 | K861036 | 000 |