Device Classification Name |
Endoscopic Contamination Prevention Sheath
|
510(k) Number |
K060475 |
Device Name |
EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -9058
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
NEIL E DEVINE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/23/2006 |
Decision Date | 03/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|