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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K894633
Device Name CORDIS STEERABLE COATED GUIDEWIRE
Applicant
CORDIS CORP.
P.O. BOX 025700
MIAMI,  FL  33102
Applicant Contact ROSEMARY SERBENT
Correspondent
CORDIS CORP.
P.O. BOX 025700
MIAMI,  FL  33102
Correspondent Contact ROSEMARY SERBENT
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/24/1989
Decision Date 10/17/1989
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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