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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mercy Tape 2d And 3d Models
510(k) Number K142469
Device Name 2D Mercy TAPE & 3D Mercy TAPE
Applicant
Children'S Mercy Hospital
2401 Gilham Rd., Suite 0411
Kansas City,  MO  64108
Applicant Contact Susan Abdel-Rahman
Correspondent
The Emmes Corporation
401 N. Washington St., Suite 700
Rockville,  MD  20850 -1785
Correspondent Contact Jan S Peterson
Regulation Number878.4800
Classification Product Code
PIR  
Date Received09/03/2014
Decision Date 05/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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