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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stripper, artery, intraluminal
510(k) Number K894496
Device Name OLYMPUS VALVULOTOME W/FIXED TIP
Applicant
OLYMPUS CORP.
4 nevada dr.
lake success,  NY  11042
Applicant Contact rick geoffrion
Correspondent
OLYMPUS CORP.
4 nevada dr.
lake success,  NY  11042
Correspondent Contact rick geoffrion
Regulation Number870.4875
Classification Product Code
DWX  
Date Received07/19/1989
Decision Date 10/12/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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