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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 K191930
Device Name 7 mm Extended Length Endoscope
Applicant
Maquet Cardiovascular, LLC
45 Barbour Pond Drive
Wayne,  NJ  07470
Applicant Contact Mark Dinger
Correspondent
Maquet Cardiovascular, LLC
45 Barbour Pond Drive
Wayne,  NJ  07470
Correspondent Contact Mark Dinger
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/19/2019
Decision Date 04/15/2020
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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