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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, balloon inflation
510(k) Number K960983
Device Name MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
Applicant
MEDTRONICS INTERVENTIONAL VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Applicant Contact JOSEPH O MAGLIOZZI RAC
Correspondent
MEDTRONICS INTERVENTIONAL VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent Contact JOSEPH O MAGLIOZZI RAC
Regulation Number870.1650
Classification Product Code
MAV  
Date Received03/11/1996
Decision Date 05/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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