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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, urethral
510(k) Number K191061
Device Name Optilume Basic Urological Balloon Dilation Catheter
Applicant
Urotronic Inc
2495 Xenium Lane N
Minneapolis,  MN  55441
Applicant Contact David Perry
Correspondent
Libra Medical
8401 73rd Ave N. Suite 63
Minneapolis,  MN  55428
Correspondent Contact Ming Cheng Chew
Regulation Number876.5520
Classification Product Code
KOE  
Date Received04/22/2019
Decision Date 01/02/2020
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
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