Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K190977 |
Device Name |
Navina Smart System, Navina Classic System |
Applicant |
Dentsply Sirona |
221 West Philadelphia Street, Suite 60W |
York,
PA
17401
|
|
Applicant Contact |
Karl Nittinger |
Correspondent |
Dentsply Sirona |
221 West Philadelphia Street, Suite 60W |
York,
PA
17401
|
|
Correspondent Contact |
Karl Nittinger |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/15/2019 |
Decision Date | 11/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|