Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K972712 |
Device Name |
CORE RESISTANT HUBER INFUSION SETS |
Applicant |
ICU MEDICAL, INC. |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
ARLENE DUTCHIK |
Correspondent |
ICU MEDICAL, INC. |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
ARLENE DUTCHIK |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 07/21/1997 |
Decision Date | 10/01/1997 |
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
|
|
|