NEBULAE SRS Laparoscopic Surgical Smoke Removal System

Apparatus, Exhaust, Surgical

Northgate Technologies Inc.

The following data is part of a premarket notification filed by Northgate Technologies Inc. with the FDA for Nebulae Srs Laparoscopic Surgical Smoke Removal System.

Pre-market Notification Details

Device IDK202944
510k NumberK202944
Device Name:NEBULAE SRS Laparoscopic Surgical Smoke Removal System
ClassificationApparatus, Exhaust, Surgical
Applicant Northgate Technologies Inc. 1591 Scottsdale Court Elgin,  IL  60123
ContactTodd Gatto
CorrespondentTodd Gatto
Northgate Technologies Inc. 1591 Scottsdale Court Elgin,  IL  60123
Product CodeFYD  
CFR Regulation Number878.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2021-03-25

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