The following data is part of a premarket notification filed by New Deantronics Taiwan, Ltd. with the FDA for New Deantronics Smoke Evacuation Adapter With 10mm Connector. New Deantronics Smoke Evacuation Adapter With 22mm Connector. New Deantronics Button Switch Electrosurgical Pencil With Sa01 Adapter. New Deantronics Button Switch Electrosurgical Pencil W.
| Device ID | K152031 |
| 510k Number | K152031 |
| Device Name: | New Deantronics Smoke Evacuation Adapter With 10mm Connector. New Deantronics Smoke Evacuation Adapter With 22mm Connector. New Deantronics Button Switch Electrosurgical Pencil With SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil W |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEW DEANTRONICS TAIWAN, LTD. 12F, NO.51, SEC. 4, CHONG YANG ROAD Tu Cheng 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 | 2015-07-22 |
| Decision Date | 2015-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521751313 | K152031 | 000 |
| 30884521751303 | K152031 | 000 |
| 20884521823294 | K152031 | 000 |