The following data is part of a premarket notification filed by New Deantronics Taiwan, Ltd. with the FDA for New Deantronics Disposable Laparoscopic Electrodes, Non-coated, And Coated.
| Device ID | K153265 |
| 510k Number | K153265 |
| Device Name: | New Deantronics Disposable Laparoscopic Electrodes, Non-coated, And Coated |
| 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 | 2015-11-12 |
| Decision Date | 2016-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521550824 | K153265 | 000 |
| 20884521549002 | K153265 | 000 |
| 20884521549019 | K153265 | 000 |
| 20884521549026 | K153265 | 000 |
| 20884521549033 | K153265 | 000 |
| 20884521549040 | K153265 | 000 |
| 20884521549057 | K153265 | 000 |
| 20884521550763 | K153265 | 000 |
| 20884521550770 | K153265 | 000 |
| 20884521550787 | K153265 | 000 |
| 20884521550794 | K153265 | 000 |
| 20884521550817 | K153265 | 000 |
| 20884521550831 | K153265 | 000 |
| 20884521548982 | K153265 | 000 |
| 20884521550800 | K153265 | 000 |
| 20884521548999 | K153265 | 000 |