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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ultrasound bronchoscope
510(k) Number K070983
Device Name OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact LAURA STORMS-TYLER
Regulation Number892.1550
Classification Product Code
PSV  
Subsequent Product Codes
ITX   IYN  
Date Received04/06/2007
Decision Date 07/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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