The following data is part of a premarket notification filed by Northeast Scientific, Inc. with the FDA for Nes Reprocessed Varicose Vein Rf Catheter.
| Device ID | K090661 |
| 510k Number | K090661 |
| Device Name: | NES REPROCESSED VARICOSE VEIN RF CATHETER |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | Northeast Scientific, Inc. 29 SOUTH COMMONS ROAD Waterbury, CT 06704 |
| Contact | Craig Allmendinger |
| Correspondent | Craig Allmendinger Northeast Scientific, Inc. 29 SOUTH COMMONS ROAD 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 | 2009-03-12 |
| Decision Date | 2010-07-21 |
| Summary: | summary |