Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K011120 |
Device Name |
GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES |
Applicant |
NIPRO DIABETES SYSTEMS, INC. |
1384 COPPERFIELD COURT |
LEXINGTON,
KY
40514
|
|
Applicant Contact |
KAELYN B HADLEY |
Correspondent |
NIPRO DIABETES SYSTEMS, INC. |
1384 COPPERFIELD COURT |
LEXINGTON,
KY
40514
|
|
Correspondent Contact |
KAELYN B HADLEY |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/12/2001 |
Decision Date | 05/08/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|