Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K200678 |
Device Name |
PENTAX Medical Video Bronchoscope EB-J10 Series |
Applicant |
PENTAX of America, Inc. |
3 Paragon Drive |
Montvale,
NJ
07645 -1782
|
|
Applicant Contact |
William Goeller |
Correspondent |
PENTAX of America, Inc. |
3 Paragon Drive |
Montvale,
NJ
07645 -1782
|
|
Correspondent Contact |
William Goeller |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 03/16/2020 |
Decision Date | 07/30/2020 |
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
|
|
|