The following data is part of a premarket notification filed by New Deantronics Taiwan, Ltd. with the FDA for Trigger Switch And Cord.
| Device ID | K200455 |
| 510k Number | K200455 |
| Device Name: | Trigger Switch And Cord |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | New Deantronics Taiwan, Ltd. 12F, No. 51, Sec. 4, Chong Yang Road, Tucheng Dist., New Taipei City, TW 23675 |
| Contact | Jane Liu |
| Correspondent | Craig J. Coombs Coombs Medical Device Consulting, Inc 1100 Pacific Marina, Suite 806 Alameda, CA 94501 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-25 |
| Decision Date | 2020-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521782645 | K200455 | 000 |