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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 K992237
Device Name MEDTRONIC GT2 FUSION GUIDE WIRES
Applicant
Medtronic Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact FRED L BOUCHER
Correspondent
Medtronic Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact FRED L BOUCHER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/02/1999
Decision Date 09/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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