Device Classification Name |
i.v. start kit
|
510(k) Number |
K950184 |
Device Name |
B. BRAUN IV START KITS |
Applicant |
B. BRAUN OF AMERICA, INC. |
824 TWELFTH AVE. |
PO BOX 4027 |
BETHLEHEM,
PA
18018 -0027
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
B. BRAUN OF AMERICA, INC. |
824 TWELFTH AVE. |
PO BOX 4027 |
BETHLEHEM,
PA
18018 -0027
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 01/17/1995 |
Decision Date | 03/15/1995 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|