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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Biliary
510(k) Number K850489
Device Name ENDOSOPIC STENE MANIPULATING BALLOON
Applicant
MILL-ROSE LABORATORY
7310 CORPORATE BLVD.
MENTOR,  OH  44060 -4885
Applicant Contact MARK KOZAK
Correspondent
MILL-ROSE LABORATORY
7310 CORPORATE BLVD.
MENTOR,  OH  44060 -4885
Correspondent Contact MARK KOZAK
Regulation Number876.5010
Classification Product Code
LQR  
Date Received02/08/1985
Decision Date 04/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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