Device Classification Name |
cord, retraction
|
510(k) Number |
K200764 |
Device Name |
STATSTIX |
Applicant |
Centrix Incorporated |
770 River Road |
Shelton,
CT
06484
|
|
Applicant Contact |
Greg Moreau |
Correspondent |
MedTek LLC |
2516 Kettle Creek Court |
Lincolnton,
NC
28092
|
|
Correspondent Contact |
Roger S Mastrony |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/24/2020 |
Decision Date | 10/15/2020 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|