Device Classification Name |
Protector, Transducer, Dialysis
|
510(k) Number |
K901996 |
Device Name |
FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR |
Applicant |
FILTERTEK, INC. |
P.O. BOX 310 PRICE RD. |
HEBRON,
IL
60034
|
|
Applicant Contact |
LARRY LARKIN |
Correspondent |
FILTERTEK, INC. |
P.O. BOX 310 PRICE RD. |
HEBRON,
IL
60034
|
|
Correspondent Contact |
LARRY LARKIN |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 05/02/1990 |
Decision Date | 06/01/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|