Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K971844 |
Device Name |
MCKINLEY OUTBOUND-2 SYSTEM |
Applicant |
MCKINLEY, INC. |
4080 YOUNGFIELD ST. |
WHEAT RIDGE,
CO
80033
|
|
Applicant Contact |
BRIAN D ZDEB |
Correspondent |
MCKINLEY, INC. |
4080 YOUNGFIELD ST. |
WHEAT RIDGE,
CO
80033
|
|
Correspondent Contact |
BRIAN D ZDEB |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/19/1997 |
Decision Date | 01/23/1998 |
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
|
|
|