Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K041410 |
Device Name |
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 |
Applicant |
ICU MEDICAL INC |
129 RESERVOIR RD. |
VERNON,
CT
06066 -5705
|
|
Applicant Contact |
DALE FAIRCHILD |
Correspondent |
ICU MEDICAL INC |
129 RESERVOIR RD. |
VERNON,
CT
06066 -5705
|
|
Correspondent Contact |
DALE FAIRCHILD |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/27/2004 |
Decision Date | 07/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|