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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K201815
Device Name Dornier MAGELLAN Ureteral Access Sheath
Applicant
Dornier MedTech America Inc
1155 Roberts Blvd, Suite 100
Kennesaw,  GA  30144
Applicant Contact John Hoffer
Correspondent
Dornier MedTech America Inc
1155 Roberts Blvd, Suite 100
Kennesaw,  GA  30144
Correspondent Contact John Hoffer
Regulation Number876.1500
Classification Product Code
FED  
Date Received07/01/2020
Decision Date 11/20/2020
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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