Device Classification Name |
bronchoscope accessory
|
510(k) Number |
K171232 |
Device Name |
PeriView FLEX |
Applicant |
Olympus Surgical Technologies America |
136 Turnpike Road |
Southborough,
MA
01772 -2104
|
|
Applicant Contact |
Mary Anne Patella |
Correspondent |
Olympus Surgical Technologies America |
136 Turnpike Road |
Southborough,
MA
01772 -2104
|
|
Correspondent Contact |
Mary Anne Patella |
Regulation Number | 874.4680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/27/2017 |
Decision Date | 09/21/2017 |
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
|
|
|