Device Classification Name |
set, administration, for peritoneal dialysis, disposable
|
510(k) Number |
K042900 |
Device Name |
K.E.P. CONNECTOR AND CLIP |
Applicant |
K.E.P., LLC |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
K.E.P., LLC |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 10/19/2004 |
Decision Date | 11/05/2004 |
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
|
|
|