Device Classification Name |
tube, double lumen for intestinal decompression and/or intubation
|
510(k) Number |
K935781 |
Device Name |
ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY |
Applicant |
SHERWOOD MEDICAL CO. |
1915 OLIVE ST. |
ST. LOUIS,
MO
63103 -1625
|
|
Applicant Contact |
DENNIS POZZO |
Correspondent |
SHERWOOD MEDICAL CO. |
1915 OLIVE ST. |
ST. LOUIS,
MO
63103 -1625
|
|
Correspondent Contact |
DENNIS POZZO |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/06/1993 |
Decision Date | 01/27/1995 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|