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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti Fog Solution And Accessories, Endoscopy
510(k) Number K231822
Device Name GOLFF Sterile Anti-Fog Solution
Applicant
Batrik Medical Manufacturing, Inc.
2165 46th Ave.
Lachine,  CA H8T 2P1
Applicant Contact Suzy Bairos
Correspondent
Batrik Medical Manufacturing, Inc.
2165 46th Ave.
Lachine,  CA H8T 2P1
Correspondent Contact Suzy Bairos
Regulation Number876.1500
Classification Product Code
OCT  
Date Received06/21/2023
Decision Date 02/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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