Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K093309 |
Device Name |
PRO-LINE CT (BASIC TRAY) MODEL MR28036101 |
Applicant |
MEDCOMP (MEDICAL COMPONENTS) |
1499 DELP DRIVE |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
JEAN CALLOW |
Correspondent |
MEDCOMP (MEDICAL COMPONENTS) |
1499 DELP DRIVE |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
JEAN CALLOW |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 10/22/2009 |
Decision Date | 11/24/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|