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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K032624
Device Name MICRUS MICROCATHETER
Applicant
Micrus Corp.
610 Palomar Ave.
Sunnyvale,  CA  94085
Applicant Contact MARGARET WEBBER
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/26/2003
Decision Date 09/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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