Device Classification Name |
System, Dialysate Delivery, Single Patient
|
510(k) Number |
K003615 |
Device Name |
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS |
Applicant |
ENVIRONMENTAL TEST SYSTEMS, INC. |
P.O. BOX 4659 |
ELKHART,
IN
46514
|
|
Applicant Contact |
BRUCE G PIEKARSKI |
Correspondent |
ENVIRONMENTAL TEST SYSTEMS, INC. |
P.O. BOX 4659 |
ELKHART,
IN
46514
|
|
Correspondent Contact |
BRUCE G PIEKARSKI |
Regulation Number | 876.5820
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/22/2000 |
Decision Date | 02/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|