Device Classification Name |
Instrument, Ent Manual Surgical
|
510(k) Number |
K131709 |
Device Name |
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT |
Applicant |
ARTHROCARE CORP. |
7000 W.WILLIAM CANNON DRIVE |
BUILDING ONE |
AUSTIN,
TX
78735
|
|
Applicant Contact |
ASHLEY DAWSON |
Correspondent |
ARTHROCARE CORP. |
7000 W.WILLIAM CANNON DRIVE |
BUILDING ONE |
AUSTIN,
TX
78735
|
|
Correspondent Contact |
ASHLEY DAWSON |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 06/11/2013 |
Decision Date | 10/04/2013 |
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
|
|
|