Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K070003 |
Device Name |
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) |
Applicant |
MEDCOMP |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
JEAN CALLOW |
Correspondent |
MEDCOMP |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
JEAN CALLOW |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 01/03/2007 |
Decision Date | 05/15/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|