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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 K072097
Device Name BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
Applicant
Medical Select, Inc.
120 Southcenter Ct., Suite 400
Morrisville,  NC  27560
Applicant Contact AMY JONES
Correspondent
Medical Select, Inc.
120 Southcenter Ct., Suite 400
Morrisville,  NC  27560
Correspondent Contact AMY JONES
Regulation Number880.5700
Classification Product Code
LBI  
Date Received07/31/2007
Decision Date 10/30/2007
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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