| Device Classification Name |
set, administration, intravascular
|
|---|
| 510(K) Number |
K112073 |
|---|
| Model |
RX-2001, RX-2201, RX-2211
|
| Device Name |
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK... |
|---|
| Applicant |
| RX DEVICES LLC |
| 19200 ashville hwy |
|
landrum,
SC
29356 9021
|
|
| Contact |
charles hokanson |
| Regulation Number | 880.5440
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/20/2011 |
|---|
| Decision Date | 04/11/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
General Hospital
|
|---|
| Review Advisory Committee |
General Hospital
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
