Device Classification Name |
Instrument, Ent Manual Surgical
|
510(k) Number |
K121351 |
Device Name |
SINUS DILATION SYSTEM |
Applicant |
ENTRIGUE SURGICAL, INC. |
12672 SILICON DR. STE 150 |
SAN ANTONIO,
TX
78249
|
|
Applicant Contact |
GABRIELE G NIEDERAUER, PH.D. |
Correspondent |
ENTRIGUE SURGICAL, INC. |
12672 SILICON DR. STE 150 |
SAN ANTONIO,
TX
78249
|
|
Correspondent Contact |
GABRIELE G NIEDERAUER, PH.D. |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 05/04/2012 |
Decision Date | 08/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|