The following data is part of a premarket notification filed by Shenb Co Ltd with the FDA for Pladuo System.
| Device ID | K201735 |
| 510k Number | K201735 |
| Device Name: | PlaDuo System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ShenB Co Ltd ShenB Bldg 148 Seongsui-ro Seoul, KR 04796 |
| Contact | Oskar Lee |
| Correspondent | Connie Hoy Hoy And Associates 3916 N. Potsdam Ave #4676 Sioux Falls, SD 57104 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-25 |
| Decision Date | 2020-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800017100159 | K201735 | 000 |