The following data is part of a premarket notification filed by New Deantronics Taiwan Ltd with the FDA for Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-hook Elec.
| Device ID | K183594 |
| 510k Number | K183594 |
| Device Name: | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Elec |
| 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 1193 Sherman St 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 | 2018-12-21 |
| Decision Date | 2019-02-19 |
| Summary: | summary |