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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 K192035
Device Name EvaQMax Smoke Evacuation System
Applicant
Bio Protech, Inc.
151-3, Donghwagongdan-Ro, Munmak-Eup
Wonju-Si,  KR 200-801
Applicant Contact Namhyun Cho
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.5070
Classification Product Code
FYD  
Date Received07/30/2019
Decision Date 08/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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