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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 K935738
Device Name MEDTRONIC GCIII CORONARY GUIDING CATHETER
Applicant
MEDTRONICS INTERVENTIONAL VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Applicant Contact KENNETH A SPECTOR
Correspondent
MEDTRONICS INTERVENTIONAL VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent Contact KENNETH A SPECTOR
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/01/1993
Decision Date 05/04/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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