Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K201212 |
Device Name |
Voyant Open Fusion Device |
Applicant |
Applied Medical Resources Corp. |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Applicant Contact |
Sherif Nakhla |
Correspondent |
Applied Medical Resources Corp. |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Correspondent Contact |
Sherif Nakhla |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/05/2020 |
Decision Date | 06/05/2020 |
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
|