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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K143507
Device Name NFANT Feeding Solution
Applicant
NFANT Labs, LLC
817 West Peachtree St
Suite 320
Atlanta,  GA  30308
Applicant Contact Lou Malice
Correspondent
Regulatory Resources Group, Inc.
111 Laurel Ridge Drive
Alpharetta,  GA  30004
Correspondent Contact Julie Stephens
Regulation Number882.5050
Classification Product Code
HCC  
Date Received12/10/2014
Decision Date 09/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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