Device Classification Name |
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
|
510(k) Number |
K981286 |
Device Name |
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS |
Applicant |
ARMM, INC. |
17744 SAMPSON LN. |
HUNTINGTON BEACH,
CA
92647
|
|
Applicant Contact |
ROGER WOOD |
Correspondent |
ARMM, INC. |
17744 SAMPSON LN. |
HUNTINGTON BEACH,
CA
92647
|
|
Correspondent Contact |
ROGER WOOD |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/08/1998 |
Decision Date | 06/19/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|