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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endothelial Cell Harvesting Kit
510(k) Number K925608
Device Name SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT
Applicant
Scimed Life Systems, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55369
Applicant Contact MERCEDES P BAYANI
Correspondent
Scimed Life Systems, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55369
Correspondent Contact MERCEDES P BAYANI
Regulation Number870.4075
Classification Product Code
MFY  
Date Received11/05/1992
Decision Date 06/16/1993
Decision Substantially Equivalent - Kit (SESK)
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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