Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K053106 |
Device Name |
TEGO, MODEL D1000 |
Applicant |
ICU MEDICAL, INC. |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
DALE FAIRCHILD |
Correspondent |
ICU MEDICAL, INC. |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
DALE FAIRCHILD |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 11/04/2005 |
Decision Date | 01/10/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|