Device Classification Name |
Set, Administration, For Peritoneal Dialysis, Disposable
|
510(k) Number |
K151620 |
Device Name |
Firefly Peritoneal Dialysis Connector Disinfection System |
Applicant |
PURACATH MEDICAL, INC. |
660 4TH STREET #104 |
SAN FRANCISCO,
CA
94107
|
|
Applicant Contact |
JOHN ASHLEY |
Correspondent |
PURACATH MEDICAL, INC. |
660 4TH STREET #104 |
SAN FRANCISCO,
CA
94107
|
|
Correspondent Contact |
JOHN ASHLEY |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 06/16/2015 |
Decision Date | 01/20/2016 |
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
|
|
|