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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K951802
Device Name SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
Applicant
Scimed Life Systems, Inc.
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact DIANE M LOWE
Correspondent
Scimed Life Systems, Inc.
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact DIANE M LOWE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received04/19/1995
Decision Date 07/21/1995
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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