Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K121035 |
Device Name |
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US |
Applicant |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
10 HIGH POINT DRIVE |
WAYNE,
NJ
07470
|
|
Applicant Contact |
GINA WALLJASPER |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 874.4680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/05/2012 |
Decision Date | 06/04/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|