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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K132713
Device Name NMI COAXIAL MICROINTRODUCER SET
Applicant
Navilyst Medical, Inc.
26 Forest St.
Marlborough,  MA  01752
Applicant Contact MICHAEL P HANLEY
Correspondent
Navilyst Medical, Inc.
26 Forest St.
Marlborough,  MA  01752
Correspondent Contact MICHAEL P HANLEY
Regulation Number870.1310
Classification Product Code
DRE  
Date Received08/30/2013
Decision Date 09/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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