Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K222284 |
Device Name |
Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) |
Applicant |
Applied Medical Resources Corporation |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Applicant Contact |
Blake Stacy |
Correspondent |
Applied Medical Resources Corporation |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Correspondent Contact |
Blake Stacy |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/01/2022 |
Decision Date | 10/14/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|