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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 K122190
Device Name PRELUDE 7F SHORT SHEATH INTRODUCER
Applicant
Merit Medical Systems, Inc.
1111 S. Velasco St.
Angleton,  TX  77515
Applicant Contact DAN CLARK
Correspondent
Merit Medical Systems, Inc.
1111 S. Velasco St.
Angleton,  TX  77515
Correspondent Contact DAN CLARK
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/24/2012
Decision Date 08/17/2012
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
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