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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K143117
Device Name Wire Sterilization Package with Indicators
Applicant
American Orthodontics
3524 Washington Ave.
Sheboygan,  WI  53081
Applicant Contact TRANG ADAMS
Correspondent
American Orthodontics
3524 Washington Ave.
Sheboygan,  WI  53081
Correspondent Contact TRANG ADAMS
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received10/30/2014
Decision Date 10/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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