Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K163537 |
Device Name |
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga |
Applicant |
Covidien llc |
161 Cheshire Lane, Suite 100 |
Plymouth,
MN
55441
|
|
Applicant Contact |
LeeAnne Swiridow |
Correspondent |
Covidien llc |
161 Cheshire Lane, Suite 100 |
Plymouth,
MN
55441
|
|
Correspondent Contact |
LeeAnne Swiridow |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 12/16/2016 |
Decision Date | 04/21/2017 |
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
|
|
|