The following data is part of a premarket notification filed by Northeast Scientific, Inc. (nes) with the FDA for Nes Reprocessed Rf Stylet (rfs).
| Device ID | K173214 |
| 510k Number | K173214 |
| Device Name: | NES Reprocessed RF Stylet (RFS) |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | Northeast Scientific, Inc. (NES) 2142 Thomaston Avenue Waterbury, CT 06704 |
| Contact | Matthew Farley |
| Correspondent | Matthew Farley Northeast Scientific, Inc. (NES) 2142 Thomaston Avenue Waterbury, CT 06704 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B227RRFS2612 | K173214 | 000 |
| B227RRFS26120 | K173214 | 000 |