Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K081210 |
Device Name |
NIPRO SAFETOUCH HUBER INFUSTION SET |
Applicant |
NIPRO MEDICAL CORP. |
3150 NW 107TH AVE. |
MIAMI,
FL
33172
|
|
Applicant Contact |
JESSICA OSWALD |
Correspondent |
NIPRO MEDICAL CORP. |
3150 NW 107TH AVE. |
MIAMI,
FL
33172
|
|
Correspondent Contact |
JESSICA OSWALD |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/29/2008 |
Decision Date | 10/21/2008 |
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
|
Recalls |
CDRH Recalls
|
|
|