NEBULAE SRS Laparoscopic Surgical Smoke Removal System— 510(k) K202944

Substantially Equivalent

Northgate Technologies, Inc.

FDA 510(k) clearance K202944 for NEBULAE SRS Laparoscopic Surgical Smoke Removal System, Substantially Equivalent on 2021-03-25. Applicant: Northgate Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Northgate Technologies, Inc.
Product code
Code FYD
Device class
Class 2
Regulation
21 CFR 878.5070
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Elgin, IL, US
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