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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, fistula
510(k) Number K171505
Device Name Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
Applicant
Dimesol, Inc.
509 Fishing Creek Road
Lewisberry,  PA  17339
Applicant Contact Stephen P. Callaghan
Correspondent
Frost Brown Todd LLC
10 West Broad Street, Suite 2300
Columbus,,  OH  43215
Correspondent Contact Courtney J. Miller
Regulation Number876.5540
Classification Product Code
FIE  
Date Received05/23/2017
Decision Date 05/17/2018
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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