Device Classification Name |
dialyzer, capillary, hollow fiber
|
510(k) Number |
K981253 |
Device Name |
ULTRACON ULTRAFILTRATOR |
Applicant |
INTERPORE INTL. |
181 TECHNOLOGY DR. |
IRVINE,
CA
92618 -2402
|
|
Applicant Contact |
LYNN M RODARTI |
Correspondent |
INTERPORE INTL. |
181 TECHNOLOGY DR. |
IRVINE,
CA
92618 -2402
|
|
Correspondent Contact |
LYNN M RODARTI |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/06/1998 |
Decision Date | 12/11/1998 |
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
|
|
|