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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K202944
Device Name NEBULAE SRS Laparoscopic Surgical Smoke Removal System
Applicant
Northgate Technologies, Inc.
1591 Scottsdale Ct.
Elgin,  IL  60123
Applicant Contact Todd Gatto
Correspondent
Northgate Technologies, Inc.
1591 Scottsdale Ct.
Elgin,  IL  60123
Correspondent Contact Todd Gatto
Regulation Number878.5070
Classification Product Code
FYD  
Date Received09/30/2020
Decision Date 03/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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