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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stabilizer, Heart, Non-Compression, Reprocessed
510(k) Number K063844
FOIA Releasable 510(k) K063844
Device Name REPROCESSED HEART STABILIZERS AND POSITIONERS
Applicant
Sterilmed, Inc.
11140 73rd Ave. N.
Maple Grove,  MN  55369
Applicant Contact DENNIS TOUSSAINT
Correspondent
Sterilmed, Inc.
11140 73rd Ave. N.
Maple Grove,  MN  55369
Correspondent Contact DENNIS TOUSSAINT
Regulation Number870.4500
Classification Product Code
NQG  
Date Received12/26/2006
Decision Date 03/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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