Device Classification Name |
Applicator (Laryngo-Tracheal), Topical Anesthesia
|
510(k) Number |
K172956 |
Device Name |
Medicant Mucosal Atomizer |
Applicant |
Medica Holdings, LLC |
5200 Meadows Rd Ste 150 |
Lake Oswego,
OR
97035
|
|
Applicant Contact |
George Reed |
Correspondent |
Medica Holdings, LLC |
5200 Meadows Rd Ste 150 |
Lake Oswego,
OR
97035
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.5170
|
Classification Product Code |
|
Date Received | 09/26/2017 |
Decision Date | 04/06/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|