Device Classification Name |
cuff, nerve
|
510(k) Number |
K202234 |
Device Name |
NervAlign Nerve Cuff |
Applicant |
Renerve Ltd |
Suite 3, 21 Vale Street |
North Melbourne,
AU
3051
|
|
Applicant Contact |
David Rhodes |
Correspondent |
Sloan Regulatory Consulting LLC |
322 Hart Road |
Gaithersburg,
MD
20878
|
|
Correspondent Contact |
Chris Sloan |
Regulation Number | 882.5275
|
Classification Product Code |
|
Date Received | 08/07/2020 |
Decision Date | 02/10/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|