Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K092418 |
Device Name |
ENTRACARE GASTROSTOMY FEEDING TUBE |
Applicant |
ENTRACARE, LLC |
11315 STRANGE LINE RD. |
LENEXA,
KS
66215
|
|
Applicant Contact |
BRANDON CONVERSE |
Correspondent |
ENTRACARE, LLC |
11315 STRANGE LINE RD. |
LENEXA,
KS
66215
|
|
Correspondent Contact |
BRANDON CONVERSE |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 08/06/2009 |
Decision Date | 10/23/2009 |
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
|
|
|