Device Classification Name |
Set, Administration, For Peritoneal Dialysis, Disposable
|
510(k) Number |
K812130 |
Device Name |
SPIKE GUARD |
Applicant |
CLINIPAD CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CLINIPAD CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 07/27/1981 |
Decision Date | 09/09/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|