Device Classification Name |
accessories, blood circuit, hemodialysis
|
510(k) Number |
K201207 |
Device Name |
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line |
Applicant |
Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street |
Waltham,
MA
02451
|
|
Applicant Contact |
Denise Oppermann |
Correspondent |
Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street |
Waltham,
MA
02451
|
|
Correspondent Contact |
Denise Oppermann |
Regulation Number | 876.5820
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/05/2020 |
Decision Date | 09/18/2020 |
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
|
|
|