ELECTROSURGICAL ELECTRODE

Electrode, Electrosurgical

NEW ENGLAND SURGICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Electrosurgical Electrode.

Pre-market Notification Details

Device IDK895331
510k NumberK895331
Device Name:ELECTROSURGICAL ELECTRODE
ClassificationElectrode, Electrosurgical
Applicant NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland,  MA  02370
ContactRichard Veane
CorrespondentRichard Veane
NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland,  MA  02370
Product CodeJOS  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-30
Decision Date1989-09-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841019116903 K895331 000
00841645104704 K895331 000
00841645104711 K895331 000
00841645104728 K895331 000
00841645104735 K895331 000
00841645104742 K895331 000
00841645104759 K895331 000
00841645104766 K895331 000
00841645104773 K895331 000
00841645104780 K895331 000
00841645104797 K895331 000
00841645104803 K895331 000
00841645104810 K895331 000
00841645104827 K895331 000
00841645104698 K895331 000
00841645104681 K895331 000
10841019117092 K895331 000
10841019117115 K895331 000
10841019117122 K895331 000
10841019119102 K895331 000
10841019119119 K895331 000
10841019119126 K895331 000
10841019119140 K895331 000
10841019119225 K895331 000
00841645104636 K895331 000
00841645104643 K895331 000
00841645104650 K895331 000
00841645104667 K895331 000
00841645104674 K895331 000
00841645104834 K895331 000
00841645104841 K895331 000
10841019107604 K895331 000
10841019107611 K895331 000
10841019107659 K895331 000
10841019107673 K895331 000
20841019108059 K895331 000
20841019108066 K895331 000
00841019108208 K895331 000
10841019109998 K895331 000
10841019110000 K895331 000
10841019110017 K895331 000
20841019116498 K895331 000
20841019116504 K895331 000
00841019117934 K895331 000
10841019107598 K895331 000
10841019107581 K895331 000
00841645104858 K895331 000
00841645104865 K895331 000
00841645104872 K895331 000
00841645104889 K895331 000
00841019107430 K895331 000
00841019107447 K895331 000
00841019107454 K895331 000
00841019107461 K895331 000
10841019107536 K895331 000
10841019107543 K895331 000
10841019107550 K895331 000
10841019107567 K895331 000
10841019107574 K895331 000
00841645140818 K895331 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.