Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K962230 |
Device Name |
CELSITE PORT WITH PRECONNECTED CATHETER |
Applicant |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. |
P.O. BOX 4027 |
BETHLEHEM,
PA
18018 -0027
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
B. BRAUN MEDICAL, INC. |
824 TWELFTH AVE. |
P.O. BOX 4027 |
BETHLEHEM,
PA
18018 -0027
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 06/10/1996 |
Decision Date | 12/16/1996 |
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
|
|
|