Device Classification Name |
Protector, Transducer, Dialysis
|
510(k) Number |
K862015 |
Device Name |
O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER |
Applicant |
BIPORE, INC. |
16 EDWARD ST. |
DEMAREST,
NJ
07627
|
|
Applicant Contact |
ELIZABETH KOCH |
Correspondent |
BIPORE, INC. |
16 EDWARD ST. |
DEMAREST,
NJ
07627
|
|
Correspondent Contact |
ELIZABETH KOCH |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 05/28/1986 |
Decision Date | 07/22/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|