Device Classification Name |
Tube, Tympanostomy
|
510(k) Number |
K171239 |
FOIA Releasable 510(k) |
K171239
|
Device Name |
TULA Tube Delivery System |
Applicant |
Tusker Medical |
155 Jefferson Drive Suite 200 |
Menlo Park,
CA
94025
|
|
Applicant Contact |
Pavan Sethi |
Correspondent |
Tusker Medical |
155 Jefferson Drive Suite 200 |
Menlo Park,
CA
94025
|
|
Correspondent Contact |
Pavan Sethi |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 04/27/2017 |
Decision Date | 06/28/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|