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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Biliary Mechanical
510(k) Number K903529
Device Name BML SERIES
Applicant
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Applicant Contact DANIEL J DILLON
Correspondent
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Correspondent Contact DANIEL J DILLON
Regulation Number876.4500
Classification Product Code
LQC  
Date Received08/06/1990
Decision Date 01/23/1991
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
Recalls CDRH Recalls
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