Device Classification Name |
arthroscope
|
510(k) Number |
K203526 |
Device Name |
C Scope Visualization System |
Applicant |
CIT Ortho |
26202 Detroit Road Ste 340 |
westlake,
OH
44145
|
|
Applicant Contact |
megan lecavalier |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
saint paul,
MN
55114
|
|
Correspondent Contact |
prithul bom |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 12/02/2020 |
Decision Date | 01/12/2021 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|