Device Classification Name |
Duodenoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K210710 |
Device Name |
PENTAX Medical Video Duedenoscope ED34-i10T2 |
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 | 876.1500
|
Classification Product Code |
|
Date Received | 03/10/2021 |
Decision Date | 04/09/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|