Device Classification Name |
set, administration, for peritoneal dialysis, disposable
|
510(k) Number |
K811863 |
Device Name |
STERI-TRACT |
Applicant |
ROGO ENT. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ROGO ENT. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 07/01/1981 |
Decision Date | 09/21/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|