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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 K925852
Device Name TERUMO CORONARY GUIDE WIRE
Applicant
Terumo Medical Corp.
P.O. Box 605
Elkton,  MD  21912
Applicant Contact ALAN B HERSHMAN
Correspondent
Terumo Medical Corp.
P.O. Box 605
Elkton,  MD  21912
Correspondent Contact ALAN B HERSHMAN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/17/1992
Decision Date 06/10/1993
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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