Device Classification Name |
Nasopharyngoscope (Flexible Or Rigid)
|
510(k) Number |
K944072 |
Device Name |
OLYMPUS NASAL AND SINUS ENDOSCOPES |
Applicant |
OLYMPUS AMERICA, INC. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042 -1179
|
|
Applicant Contact |
BARRY E SANDS |
Correspondent |
OLYMPUS AMERICA, INC. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042 -1179
|
|
Correspondent Contact |
BARRY E SANDS |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 08/22/1994 |
Decision Date | 01/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|