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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K982733
Device Name OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE
Applicant
The Olympus Optical Co.
Two Corporate Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TAYLOR
Correspondent
The Olympus Optical Co.
Two Corporate Dr.
Melville,  NY  11747
Correspondent Contact LAURA STORMS-TAYLOR
Regulation Number892.1570
Classification Product Code
ITX  
Date Received08/05/1998
Decision Date 10/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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