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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 K844687
Device Name MEDTRONIC MODEL 6912
Applicant
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Applicant Contact EDWARD W NUMAINVILL
Correspondent
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Correspondent Contact EDWARD W NUMAINVILL
Regulation Number870.3620
Classification Product Code
DTD  
Date Received12/03/1984
Decision Date 02/01/1985
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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