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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K904575
Device Name MODEL 5866-37M LEAD ADAPTOR KIT
Applicant
Medtronic Vascular
7000 Central Ave. N.E
Minneapolis,  MN  55432
Applicant Contact NORSTED, PHD
Correspondent
Medtronic Vascular
7000 Central Ave. N.E
Minneapolis,  MN  55432
Correspondent Contact NORSTED, PHD
Regulation Number870.3620
Classification Product Code
DTD  
Date Received10/09/1990
Decision Date 02/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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