Device Classification Name |
Instrument, Ent Manual Surgical
|
510(k) Number |
K110739 |
FOIA Releasable 510(k) |
K110739
|
Device Name |
ENTELLUS MEDICAL SINUS GUIDEWIRE |
Applicant |
Entellus Medical, Inc. |
6705 WEDGWOOD COURT NORTH |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
KAREN E PETERSON |
Correspondent |
Entellus Medical, Inc. |
6705 WEDGWOOD COURT NORTH |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
KAREN E PETERSON |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 03/17/2011 |
Decision Date | 06/14/2011 |
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
|
|
|