Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K170790 |
Device Name |
SAM CRRT Unit, SAM Cassette CRRT |
Applicant |
Spectral Medical Inc. |
135 The West Mall, Unit 2 |
Toronto,
CA
M9C 1C2
|
|
Applicant Contact |
Danijela Domljanovic |
Correspondent |
Amarex Clinical Research |
20201 Century Boulevard, 4th Floor |
Germantown,
MD
20874
|
|
Correspondent Contact |
Olga Pavlova |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 03/16/2017 |
Decision Date | 12/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|