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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 K854831
Device Name VALVOKIT
Applicant
Novamed Products, Inc.
100 Alexis Nihon 576
St. Laurent
Quebec, Canada H4m2p1,  CA
Applicant Contact SERGE TOURANGEAU
Correspondent
Novamed Products, Inc.
100 Alexis Nihon 576
St. Laurent
Quebec, Canada H4m2p1,  CA
Correspondent Contact SERGE TOURANGEAU
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/03/1985
Decision Date 03/31/1986
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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