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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K242927
Device Name Suction Irrigation Tubing Set
Applicant
Advamedix, GmbH
Greschbachstr 3/3. Og
Karlsruhe,  DE 76229
Applicant Contact Dr. Islam Abed
Correspondent
Traxn Consulting, LLC
1235 Swiftshore Circle
West Linn,  OR  97068
Correspondent Contact Marianne Jacklyn
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/24/2024
Decision Date 11/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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