Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
510(k) Number |
K811839 |
Device Name |
MEDISYSTEM NEGATIVE PRESSURE |
Applicant |
MEDISYSTEMS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Applicant Contact |
- - |
Correspondent |
MEDISYSTEMS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent Contact |
- - |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 07/01/1981 |
Decision Date | 09/08/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|