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 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 Number | 876.5820
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/29/2017 |
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
|
|
|