The following data is part of a premarket notification filed by New Deantronics Taiwan Ltd with the FDA for Monopolar Cord.
| Device ID | K193004 |
| 510k Number | K193004 |
| Device Name: | Monopolar Cord |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | New Deantronics Taiwan Ltd 12F., No.51, Sec.4, Chong Yang Rd., 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 | 2019-10-28 |
| Decision Date | 2019-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521782638 | K193004 | 000 |