Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K120953 |
Device Name |
PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM |
Applicant |
TLELFLEX MEDICAL, INC. |
2917 Weck Drive |
Research Triangle Park,
NC
27709
|
|
Applicant Contact |
LORRAINE DELONG |
Correspondent |
TLELFLEX MEDICAL, INC. |
2917 Weck Drive |
Research Triangle Park,
NC
27709
|
|
Correspondent Contact |
LORRAINE DELONG |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 03/30/2012 |
Decision Date | 12/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|