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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ureteral, Gastro-Urology
510(k) Number K191187
Device Name Dornier MINNOW Ureteral Catheter
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 Number876.5130
Classification Product Code
EYB  
Date Received05/03/2019
Decision Date 09/18/2019
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
Predetermined Change
Control Plan Authorized		 No
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