The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Polyhesive Patient Return Electrode.
| Device ID | K822572 |
| 510k Number | K822572 |
| Device Name: | POLYHESIVE PATIENT RETURN ELECTRODE |
| 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 | 1982-08-24 |
| Decision Date | 1982-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884524000609 | K822572 | 000 |
| 20884524000074 | K822572 | 000 |
| 20884524000999 | K822572 | 000 |
| 20884524001057 | K822572 | 000 |
| 20884524001040 | K822572 | 000 |
| 20884524000982 | K822572 | 000 |