Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K952548 |
Device Name |
CELSITE VENOUS SYSTEM |
Applicant |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. |
BETHLEHEM,
PA
18018
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. |
BETHLEHEM,
PA
18018
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 06/02/1995 |
Decision Date | 07/21/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|