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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valvulotome
510(k) Number K911702
Device Name OLYMPUS RETRACTABLE VALVULOTOME
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 Number870.4885
Classification Product Code
MGZ  
Date Received04/16/1991
Decision Date 12/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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