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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 Road, Suite 0411
Kansas City,  MO  64108
Applicant Contact Susan Abdel-Rahman
Correspondent
The EMMES Corporation
401 N Washington St, Ste 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
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