Device Classification Name |
dialyzer, capillary, hollow fiber
|
510(k) Number |
K971710 |
Device Name |
ULTRACON ULTRAFILTRATOR |
Applicant |
QUANTIC BIOMEDICAL, INC. |
810 "E" ST. |
SAN RAFAEL,
CA
94901 -2819
|
|
Applicant Contact |
ANDREW G HOOD |
Correspondent |
QUANTIC BIOMEDICAL, INC. |
810 "E" ST. |
SAN RAFAEL,
CA
94901 -2819
|
|
Correspondent Contact |
ANDREW G HOOD |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 05/08/1997 |
Decision Date | 02/27/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|