Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K102712 |
Device Name |
MED GRAVITY SET, IMED PUMP SET |
Applicant |
IMED TECHNOLOGY, INC. |
17408 TAMARON DRIVE |
DALLAS,
TX
75287
|
|
Applicant Contact |
BRANDON CONVERSE |
Correspondent |
IMED TECHNOLOGY, INC. |
17408 TAMARON DRIVE |
DALLAS,
TX
75287
|
|
Correspondent Contact |
BRANDON CONVERSE |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/20/2010 |
Decision Date | 12/16/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|