Device Classification Name |
syringe, piston
|
510(k) Number |
K090162 |
Device Name |
EVICEL APPLICATION DEVICE |
Applicant |
OMRIX BIOPHARMACEUTICALS LTD. |
MDA BLOOD BANK |
SHEBA HOSPITAL, TEL HASHOMER |
RAMAT GAN,
IL
52621
|
|
Applicant Contact |
SARA HORN |
Correspondent |
OMRIX BIOPHARMACEUTICALS LTD. |
MDA BLOOD BANK |
SHEBA HOSPITAL, TEL HASHOMER |
RAMAT GAN,
IL
52621
|
|
Correspondent Contact |
SARA HORN |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 01/22/2009 |
Decision Date | 02/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|