Device Classification Name |
catheter, peritoneal, long-term indwelling
|
510(k) Number |
K121383 |
Device Name |
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) |
Applicant |
MEDICAL COMPONENTS INC |
1499 DELP DRIVE |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
JEAN CALLOW |
Correspondent |
MEDICAL COMPONENTS INC |
1499 DELP DRIVE |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
JEAN CALLOW |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 05/08/2012 |
Decision Date | 09/05/2012 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|