Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K132142 |
Device Name |
NERIA SOFT 90 INFUSION SET |
Applicant |
UNOMEDICAL A/S |
UNIT B9, TAYLORS COURT, PARKGATE |
ROTHERHAM, SOUTH YORKSHIRE,
GB
S62 6NU
|
|
Applicant Contact |
DEIRDRE BARROW |
Correspondent |
UNOMEDICAL A/S |
UNIT B9, TAYLORS COURT, PARKGATE |
ROTHERHAM, SOUTH YORKSHIRE,
GB
S62 6NU
|
|
Correspondent Contact |
DEIRDRE BARROW |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 07/11/2013 |
Decision Date | 10/08/2013 |
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
|
|
|