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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K161249
Device Name Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
Applicant
Medtronic
1801 E. Deere Ave.
Santa Ana,  CA  92705
Applicant Contact Debra Taitague
Correspondent
Medtronic
1801 E. Deere Ave.
Santa Ana,  CA  92705
Correspondent Contact Debra Taitague
Regulation Number870.3680
Classification Product Code
LDF  
Date Received05/03/2016
Decision Date 08/19/2016
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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