Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K941228 |
Device Name |
ENDOLUMINAL ACCESS TUBE |
Applicant |
MED INSTITUTE, INC. |
P.O. BOX 2402 |
WEST LAFAYETTE,
IN
47906
|
|
Applicant Contact |
NEAL E FEARNOT |
Correspondent |
MED INSTITUTE, INC. |
P.O. BOX 2402 |
WEST LAFAYETTE,
IN
47906
|
|
Correspondent Contact |
NEAL E FEARNOT |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/15/1994 |
Decision Date | 09/27/1995 |
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
|
|
|