Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K833034 |
Device Name |
UNIVERSAL VENTED & NON/VOLUME INFUS- |
Applicant |
Y |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
Y |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/07/1983 |
Decision Date | 11/07/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|