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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 K132008
Device Name 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
Applicant
MEDTRONIC INC.
8200 CORAL SEA STREET
MOUNDS VIEW,  MN  55112
Applicant Contact MICHELE MACHACEK
Correspondent
MEDTRONIC INC.
8200 CORAL SEA STREET
MOUNDS VIEW,  MN  55112
Correspondent Contact MICHELE MACHACEK
Regulation Number870.3620
Classification Product Code
DTD  
Date Received07/01/2013
Decision Date 07/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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