Device Classification Name |
Nasopharyngoscope (Flexible Or Rigid)
|
510(k) Number |
K132433 |
Device Name |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
Applicant |
ACCLARENT, INC. |
1525-B OBRIEN DR. |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
JAMES PATRICK GARVEY II |
Correspondent |
ACCLARENT, INC. |
1525-B OBRIEN DR. |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
JAMES PATRICK GARVEY II |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 08/05/2013 |
Decision Date | 04/24/2014 |
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
|
|
|