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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 K942269
Device Name MEDTRONIC EVEREST INFLATION DEVICE
Applicant
MEDTRONICS INTERVENTIONAL VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Applicant Contact JOSEPH O MAGLIOZZI
Correspondent
MEDTRONICS INTERVENTIONAL VASCULAR
37A CHERRY HILL DR.
DANVERS,  MA  01923
Correspondent Contact JOSEPH O MAGLIOZZI
Regulation Number870.1650
Classification Product Code
MAV  
Date Received05/10/1994
Decision Date 10/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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