Device Classification Name |
nasopharyngoscope (flexible or rigid)
|
510(k) Number |
K021073 |
Device Name |
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V |
Applicant |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Correspondent Contact |
LAURA STORMS-TYLER |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 04/02/2002 |
Decision Date | 05/01/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|