Device Classification Name |
Nasopharyngoscope (Flexible Or Rigid)
|
510(k) Number |
K171011 |
Device Name |
PENTAX Medical VIVIDEO ENT Videoscope Solution |
Applicant |
Pentax Medical |
3 Paragon Drive |
Montvale,
NJ
07645
|
|
Applicant Contact |
James W. Monroe |
Correspondent |
Pentax Medical |
3 Paragon Drive |
Montvale,
NJ
07645
|
|
Correspondent Contact |
William Goeller |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 04/04/2017 |
Decision Date | 07/18/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|