Device Classification Name |
ear, nose, and throat stereotaxic instrument
|
510(k) Number |
K162176 |
Device Name |
Fiagon Navigation System |
Applicant |
Fiagon GmbH |
Neuendorfstrasse 23b |
Hennigsdorf,
DE
16761
|
|
Applicant Contact |
Dirk Mucha |
Correspondent |
Hogan Lovells US LLP |
3 Embarcadero Center, Suite 1500 |
San Francisco,
CA
94111
|
|
Correspondent Contact |
Yarmela Pavlovic |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 08/03/2016 |
Decision Date | 12/01/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|