Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K161413 |
Device Name |
Low Profile Balloon Feeding Device |
Applicant |
APPLIED MEDICAL TECHNOLOGY, INC. |
8006 KATHERINE BLVD |
BRECKSVILLE,
OH
44141
|
|
Applicant Contact |
Michelle Scott |
Correspondent |
APPLIED MEDICAL TECHNOLOGY, INC. |
8006 KATHERINE BLVD |
BRECKSVILLE,
OH
44141
|
|
Correspondent Contact |
Michelle Scott |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 05/23/2016 |
Decision Date | 02/09/2017 |
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
|
|
|