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 |