Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K042172 |
FOIA Releasable 510(k) |
K042172
|
Device Name |
CLEO 90 INFUSION SET |
Applicant |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX ROAD |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
DAVID H SHORT |
Correspondent |
SMITHS MEDICAL MD, INC. |
1265 GREY FOX ROAD |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
DAVID H SHORT |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/11/2004 |
Decision Date | 10/07/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|