Device Classification Name |
set, dialyzer holder
|
510(k) Number |
K843504 |
Device Name |
AMER. BENTLEY HEMOFILTER HOLDER HFH-1 |
Applicant |
AMERICAN BENTLEY |
17502 ARMSTRONG AVE. |
IRVINE,
CA
92714
|
|
Applicant Contact |
DONALD A RAIBLE |
Correspondent |
AMERICAN BENTLEY |
17502 ARMSTRONG AVE. |
IRVINE,
CA
92714
|
|
Correspondent Contact |
DONALD A RAIBLE |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 09/06/1984 |
Decision Date | 10/18/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|