NES REPROCESSED ENDOSCOPIC TROCAR

Laparoscope, General & Plastic Surgery, Reprocessed

Northeast Scientific, Inc.

The following data is part of a premarket notification filed by Northeast Scientific, Inc. with the FDA for Nes Reprocessed Endoscopic Trocar.

Pre-market Notification Details

Device IDK060676
510k NumberK060676
Device Name:NES REPROCESSED ENDOSCOPIC TROCAR
ClassificationLaparoscope, General & Plastic Surgery, Reprocessed
Applicant Northeast Scientific, Inc. 29 SOUTH COMMONS ROAD Waterbury,  CT  06704
ContactCraig Allmendinger
CorrespondentCraig Allmendinger
Northeast Scientific, Inc. 29 SOUTH COMMONS ROAD Waterbury,  CT  06704
Product CodeNLM  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-14
Decision Date2007-09-07
Summary:summary

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