Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K925261 |
Device Name |
NUTRICARE ENTERAL FEEDING TUBE |
Applicant |
ENTRACARE CORP. |
15731 WEST 100TH TERRACE |
LENEXA,
KS
66219
|
|
Applicant Contact |
AL BOEDEKER |
Correspondent |
ENTRACARE CORP. |
15731 WEST 100TH TERRACE |
LENEXA,
KS
66219
|
|
Correspondent Contact |
AL BOEDEKER |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 10/19/1992 |
Decision Date | 02/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|