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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 K982883
Device Name MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
Applicant
MEDTRONICS INTERVENTIONAL VASCULAR
35-37A CHERRY HILL DR.
DANVERS,  MA  01923
Applicant Contact MARK CHARTIER
Correspondent
MEDTRONICS INTERVENTIONAL VASCULAR
35-37A CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent Contact MARK CHARTIER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/17/1998
Decision Date 09/04/1998
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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