The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Electrosurgical Electrode.
| Device ID | K895331 |
| 510k Number | K895331 |
| Device Name: | ELECTROSURGICAL ELECTRODE |
| Classification | Electrode, Electrosurgical |
| Applicant | NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370 |
| Contact | Richard Veane |
| Correspondent | Richard Veane NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-30 |
| Decision Date | 1989-09-15 |