Device Classification Name |
set, i.v. fluid transfer
|
510(k) Number |
K925401 |
Device Name |
IV FLUID TRANSFER PIN |
Applicant |
B. BRAUN OF AMERICA, INC. |
824 TWELFTH AVE. |
PO BOX 4027 |
BETHLEHEM,
PA
18018 -0027
|
|
Applicant Contact |
CHRISTINE HARRIS |
Correspondent |
B. BRAUN OF AMERICA, INC. |
824 TWELFTH AVE. |
PO BOX 4027 |
BETHLEHEM,
PA
18018 -0027
|
|
Correspondent Contact |
CHRISTINE HARRIS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/26/1992 |
Decision Date | 03/03/1993 |
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
|
|
|