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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Catheter Control, Steerable
510(k) Number K904787
Device Name CRI STEERABLE CATHETER CONTROL SYSTEM
Applicant
Catheter Research C/O Burditt, Bowles & Radzius
6131 W. 80th St.
Indianapolis,  IN  46278
Applicant Contact BRIAN GRIGSBY
Correspondent
Catheter Research C/O Burditt, Bowles & Radzius
6131 W. 80th St.
Indianapolis,  IN  46278
Correspondent Contact BRIAN GRIGSBY
Regulation Number870.1290
Classification Product Code
DXX  
Date Received10/23/1990
Decision Date 12/17/1990
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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