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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K163526
Device Name Bilicocoon™ Phototherapy System
Applicant
Neomedlight
89-90 Rue Frederic Fays
Villeurbanne,  FR 69100
Applicant Contact Pierre Saint Girons
Correspondent
Neomedlight
89-90 Rue Frederic Fays
Villeurbanne,  FR 69100
Correspondent Contact Pierre Saint Girons
Regulation Number880.5700
Classification Product Code
LBI  
Date Received12/16/2016
Decision Date 10/06/2017
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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