Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K050907 |
Device Name |
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P |
Applicant |
FUJINON, INC. |
543 LONG HILL AVENUE |
SHELTON,
CT
06484
|
|
Applicant Contact |
JOSEPH AZARY |
Correspondent |
FUJINON, INC. |
543 LONG HILL AVENUE |
SHELTON,
CT
06484
|
|
Correspondent Contact |
JOSEPH AZARY |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 04/11/2005 |
Decision Date | 05/19/2005 |
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
|
|
|