Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K031554 |
Device Name |
S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM |
Applicant |
GENZYME BIOSURGERY |
600 AIRPORT RD. |
FALL RIVER,
MA
02720 -4740
|
|
Applicant Contact |
DENISE LIMA |
Correspondent |
GENZYME BIOSURGERY |
600 AIRPORT RD. |
FALL RIVER,
MA
02720 -4740
|
|
Correspondent Contact |
DENISE LIMA |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 05/19/2003 |
Decision Date | 07/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|