Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K850979 |
Device Name |
HEMOCONCENTRATOR KIT |
Applicant |
OMNIS SURGICAL, INC. |
1 BAXTER PARKWAY 3-2W |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
THOMAS D NICKEL |
Correspondent |
OMNIS SURGICAL, INC. |
1 BAXTER PARKWAY 3-2W |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
THOMAS D NICKEL |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 03/08/1985 |
Decision Date | 07/29/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|