Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K954429 |
Device Name |
KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT |
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 | 09/22/1995 |
Decision Date | 03/08/1996 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|