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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 K191174
Device Name Mercy babyTAPE
Applicant
Children'S Mercy Hospital
2401 Gilham Rd.
Kansas City,  MO  64108
Applicant Contact Susan Abdel-Rahman
Correspondent
The Emmes Company, LLC
Children'S Mercy Hospital
2401 Gilham Rd.
Kanas City,  MO  64108
Correspondent Contact Susan Abdel-Rahman, Pharmd.
Regulation Number878.4800
Classification Product Code
PIR  
Subsequent Product Codes
FRW   FTY  
Date Received05/01/2019
Decision Date 10/10/2019
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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