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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K874117
Device Name MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Applicant Contact ALAN MARQUARDT
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. N.E.
MINNEAPOLIS,  MN  55432
Correspondent Contact ALAN MARQUARDT
Regulation Number870.1240
Classification Product Code
DYG  
Date Received10/09/1987
Decision Date 11/05/1987
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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