Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K901089 |
Device Name |
LOW VOLUME TRIFURCATED IV EXTENSION SET |
Applicant |
MARQUETTE MEDICAL, INC. |
2134 ESPEY CT. #7 |
CROFTON,
MD
21114
|
|
Applicant Contact |
MARQUETTE, JR |
Correspondent |
MARQUETTE MEDICAL, INC. |
2134 ESPEY CT. #7 |
CROFTON,
MD
21114
|
|
Correspondent Contact |
MARQUETTE, JR |
Regulation Number | 880.5440 |
Classification Product Code |
|
Date Received | 03/07/1990 |
Decision Date | 10/04/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|