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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K142484
Device Name Sternal Closure System
Applicant
JACE Medical LLC
536 East 200 North
Warsaw,  IN  46582
Applicant Contact Justin May
Correspondent
BackRoads Consulting Inc.
PO Box 566
Chesterland,  OH  44026 -2141
Correspondent Contact Karen E Warden
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   JDQ  
Date Received09/04/2014
Decision Date 10/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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