Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K903641 |
Device Name |
QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q |
Applicant |
BENTLEY LABORATORIES, INC. |
P.O. BIX 19522 |
IRVINE,
CA
92713
|
|
Applicant Contact |
DONALD RAILBE |
Correspondent |
BENTLEY LABORATORIES, INC. |
P.O. BIX 19522 |
IRVINE,
CA
92713
|
|
Correspondent Contact |
DONALD RAILBE |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 08/14/1990 |
Decision Date | 11/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|