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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 K924202
Device Name RADIFOCUS(R) (CATHETER) GUIDE WIRE
Applicant
TERUMO MEDICAL CORP.
P.O. BOX 605
ELKTON,  MD  21912
Applicant Contact GEORGE S MOMODA
Correspondent
TERUMO MEDICAL CORP.
P.O. BOX 605
ELKTON,  MD  21912
Correspondent Contact GEORGE S MOMODA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/20/1992
Decision Date 11/23/1992
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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