Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K102548 |
Device Name |
FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE |
Applicant |
FOOTPRINT MEDICAL INC. |
1203 CAMDEN STREET |
SAN ANTONIO,
TX
78215
|
|
Applicant Contact |
CLYDE N BAKER |
Correspondent |
FOOTPRINT MEDICAL INC. |
1203 CAMDEN STREET |
SAN ANTONIO,
TX
78215
|
|
Correspondent Contact |
CLYDE N BAKER |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/03/2010 |
Decision Date | 11/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|