Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K163435 |
Device Name |
Entellus Medical Reinforced Anesthesia Needle |
Applicant |
Entellus Medical Inc. |
3600 Holly Lane North, Suite 40 |
Plymouth,
MN
55447
|
|
Applicant Contact |
Megan Bernier |
Correspondent |
Entellus Medical Inc. |
3600 Holly Lane North, Suite 40 |
Plymouth,
MN
55447
|
|
Correspondent Contact |
Karen Peterson |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 12/07/2016 |
Decision Date | 04/05/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|