The following data is part of a premarket notification filed by E Surgical, Llc with the FDA for E Surgical Electrosurgical Patient Return Electrode, Dual Plate With Cord And Electrosurgical Patient Return Electrode.
| Device ID | K060255 |
| 510k Number | K060255 |
| Device Name: | E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | E SURGICAL, LLC 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward E SURGICAL, LLC 4655 KIRKWOOD COURT 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 | 2006-02-01 |
| Decision Date | 2006-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888867062594 | K060255 | 000 |
| 30614559100879 | K060255 | 000 |