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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infant Positioner, Rx, Use In Highly Monitored Setting
510(k) Number K172962
Device Name Nurture Rest
Applicant
Neonatal Loving Kare, Inc.
1702 Treasure Lake
Dubois,  PA  15801
Applicant Contact Nicole Sawyers
Correspondent
Regulatory and Quality Solutions, Inc.
2790 Mosside Blvd.
#800
Monroeville,  PA  15146
Correspondent Contact Nicole Spaniel
Regulation Number880.5680
Classification Product Code
OUW  
Subsequent Product Code
FRP  
Date Received09/26/2017
Decision Date 01/18/2018
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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