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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K171952
Device Name Dimesol Tubing Sets for Hemodialysis
Applicant
Dimesol, Inc.
509 Fishing Creek Rd.
Lewisberry,  PA  17339
Applicant Contact Stephen P. Callaghan
Correspondent
Frost Brown Todd, LLC
10 W. Broad St., Suite 2300
Columbus,  OH  43215
Correspondent Contact Courtney J. Miller
Regulation Number876.5820
Classification Product Code
FJK  
Subsequent Product Code
FKB  
Date Received06/29/2017
Decision Date 03/30/2018
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
Predetermined Change
Control Plan Authorized		 No
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