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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K171206
Device Name D'Vill Introducer
NuMED, Inc.
2880 Main Street
Hopkinton,  NY  12965
Applicant Contact Nichelle LaFlesh
NuMED, Inc.
2880 Main Street
Hopkinton,  NY  12965
Correspondent Contact Nichelle LaFlesh
Regulation Number870.1340
Classification Product Code
Date Received04/25/2017
Decision Date 10/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No