Device Classification Name |
Instrument, Ent Manual Surgical
|
510(k) Number |
K091681 |
Device Name |
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) |
Applicant |
Entellus Medical, Inc. |
6705 WEDGWOOD COURT NORTH |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
DEBORAH I NEYMARK |
Correspondent |
Entellus Medical, Inc. |
6705 WEDGWOOD COURT NORTH |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
DEBORAH I NEYMARK |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 06/10/2009 |
Decision Date | 07/08/2009 |
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
|
|
|