Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K120395 |
Device Name |
NERIA MULTI SUBCUTANEOUS INFUSION SET |
Applicant |
UNOMEDICAL DEVICES S.A DE C.V |
Avenida Fomento Industrial Lote 9 Manzana 3 |
Parque Industrial Del Norte |
Reynosa,
MX
C.P. 88736
|
|
Applicant Contact |
JOHN M LINDSKOG |
Correspondent |
UNOMEDICAL DEVICES S.A DE C.V |
Avenida Fomento Industrial Lote 9 Manzana 3 |
Parque Industrial Del Norte |
Reynosa,
MX
C.P. 88736
|
|
Correspondent Contact |
JOHN M LINDSKOG |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/08/2012 |
Decision Date | 05/30/2012 |
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
|
|
|