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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
Number
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Decision
Date
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pacing lead model 6991a Medtronic Vascular k772104 11/28/1977
medtronic model 5013 Medtronic Vascular k863536 01/06/1987
vacuum bake cycle Medtronic Vascular k904892 12/20/1990
metronic sofamor danek cement restrictor Medtronic Sofamor Danek, Inc. k011998 07/26/2001
schooltable Mednet, Inc. k862894 08/13/1986
medix biotech prolactin enzyme immuno. test kit Medix Biotech, Inc. k873355 10/09/1987
modified ferritin enzyme immunoassay test kit Medix Biotech, Inc. k896585 12/04/1989
single size tendon spacer Medist International k000019 03/29/2000
mediclung, release 1 Medicsight k033412 12/30/2003
mysafety syringe Medicalchain Internartional Corporation k113673 08/03/2012

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