Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K162770 |
Device Name |
Relign System |
Applicant |
Relign Corporation |
1601 South De Anza Boulevard, Suite 200 |
Cupertino,
CA
95014
|
|
Applicant Contact |
Nathan Nguyen |
Correspondent |
Relign Corporation |
1601 South De Anza Boulevard, Suite 200 |
Cupertino,
CA
95014
|
|
Correspondent Contact |
Nathan Nguyen |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/03/2016 |
Decision Date | 01/04/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|