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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K181132
Device Name Tri-Ad 2.0 Adams Tricuspid Band
Applicant
Medtronic
1851 E. Deere Ave.
Santa Ana,  CA  92705
Applicant Contact Tracy Gray
Correspondent
Medtronic
1851 E. Deere Ave.
Santa Ana,  CA  92705
Correspondent Contact Tracy Gray
Regulation Number870.3800
Classification Product Code
KRH  
Date Received04/30/2018
Decision Date 05/29/2018
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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