The following data is part of a premarket notification filed by New Deantronics Taiwan, Ltd with the FDA for New Deantronics E Green™ Electrosurgical Monopolar Pencils.
| Device ID | K170161 |
| 510k Number | K170161 |
| Device Name: | New Deantronics E Green™ Electrosurgical Monopolar Pencils |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | New Deantronics Taiwan, LTD 12F,No.51,Sec.4, Chong Yang Road, Tu Cheng Dist. New Taipei City, TW 23675 |
| Contact | Jane Liu |
| Correspondent | Lewis Ward L.W. Ward And Associates, Inc. 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 | 2017-01-18 |
| Decision Date | 2017-03-29 |
| Summary: | summary |