Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K131183 |
Device Name |
MED-RX ORAL/ENTERAL SYRINGE |
Applicant |
BENLAN, INC. |
2760 BRIGHTON RD. |
OAKVILLE, ONTARIO,
CA
L6H 5T4
|
|
Applicant Contact |
CHERYL BROWN |
Correspondent |
BENLAN, INC. |
2760 BRIGHTON RD. |
OAKVILLE, ONTARIO,
CA
L6H 5T4
|
|
Correspondent Contact |
CHERYL BROWN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/26/2013 |
Decision Date | 06/03/2014 |
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
|
|
|