Device Classification Name |
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
|
510(k) Number |
K133439 |
Device Name |
PILLING ESOPHAGEAL BOUGIES |
Applicant |
Teleflex Medical, Inc. |
2917 WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Applicant Contact |
HOLLY KORNEGAY |
Correspondent |
Teleflex Medical, Inc. |
2917 WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Correspondent Contact |
HOLLY KORNEGAY |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 11/12/2013 |
Decision Date | 06/16/2014 |
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
|
|
|