Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K772036 |
Device Name |
IN-LINE BURETTE SET |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/27/1977 |
Decision Date | 11/16/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|