Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K112434 |
Device Name |
BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION |
Applicant |
BD MEDICAL SURGICAL |
ONE BECTON DR. MC237 |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
JOHN ROBERTS |
Correspondent |
BD MEDICAL SURGICAL |
ONE BECTON DR. MC237 |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
JOHN ROBERTS |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 08/24/2011 |
Decision Date | 09/29/2011 |
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
|
|
|