| Device Classification Name |
apparatus, autotransfusion
|
|---|
| 510(K) Number |
K120953 |
|---|
| Models |
A-1500-08LF,
S-100-08LF,
S-1150-08LF
|
| Device Name |
PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM |
|---|
| Applicant |
| TLELFLEX MEDICAL, INC. |
| 2917 weck drive |
|
research triangle park,
NC
27709
|
|
| Contact |
lorraine delong |
| Regulation Number | 868.5830
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/30/2012 |
|---|
| Decision Date | 12/10/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Anesthesiology
|
|---|
| Review Advisory Committee |
Cardiovascular
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
