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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 K870700
Device Name MICRO-GUIDE
Applicant
Catheter Research C/O Burditt, Bowles & Radzius
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Applicant Contact JOSEPH R RADZIUS
Correspondent
Catheter Research C/O Burditt, Bowles & Radzius
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Correspondent Contact JOSEPH R RADZIUS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/19/1987
Decision Date 12/03/1987
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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