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510(k) K060475

EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 by Olympus Medical Systems Corporation — Product Code ODB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2006
Date Received
February 23, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Endoscopic Contamination Prevention Sheath
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To protect an endoscope from contamination by providing a barrier between the body and the endoscope.

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