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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reprocessed Intravascular Ultrasound Catheter
510(k) Number K043453
Device Name STERILEMED REPROCESSED IVUS IMAGING CATHETER
Applicant
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Applicant Contact BRUCE LESTER
Correspondent
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Correspondent Contact BRUCE LESTER
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received12/15/2004
Decision Date 03/01/2005
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
Recalls CDRH Recalls
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