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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K190312
Device Name Dornier Ureteral Stent
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 Number876.4620
Classification Product Code
FAD  
Date Received02/12/2019
Decision Date 11/15/2019
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
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