The following data is part of a premarket notification filed by E Surgical, Llc with the FDA for Electrode Coated Ball, Model Ab302c; Needle, Model An301c; Blade, Model Ae301hc.
| Device ID | K061878 |
| 510k Number | K061878 |
| Device Name: | ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC |
| 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 | 2006-07-03 |
| Decision Date | 2006-10-24 |
| Summary: | summary |