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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K001969
Device Name GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
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 Number870.1250
Classification Product Code
DQY  
Date Received06/28/2000
Decision Date 08/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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