Device Classification Name |
catheter, hemodialysis, implanted
|
510(k) Number |
K210461 |
Device Name |
End Cap |
Applicant |
Medical Components Inc. (Medcomp) |
1499 Delp Drive |
Harleysville,
PA
19438
|
|
Applicant Contact |
Patrick McDonald |
Correspondent |
Medical Components Inc. (Medcomp) |
1499 Delp Drive |
Harleysville,
PA
19438
|
|
Correspondent Contact |
Patrick McDonald |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 02/16/2021 |
Decision Date | 09/14/2021 |
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
|
|
|