Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K212650 |
Device Name |
Celeris, Disposable Sinus Debrider |
Applicant |
Gyrus ACMI, Inc. |
800 West Park Drive |
Westborough,
MA
01581
|
|
Applicant Contact |
Dolan Mills |
Correspondent |
Gyrus ACMI, Inc. |
800 West Park Drive |
Westborough,
MA
01581
|
|
Correspondent Contact |
Dolan Mills |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 08/23/2021 |
Decision Date | 01/19/2022 |
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
|
|
|