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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 K190899
Device Name bili-hut
Applicant
Little Sparrows Technologies, Inc.
176 Mystic Valley Pkwy.
Winchester,  MA  01890
Applicant Contact Erica Konston
Correspondent
Little Sparrows Technologies, Inc.
176 Mystic Valley Pkwy.
Winchester,  MA  01890
Correspondent Contact Erica Konston
Regulation Number880.5700
Classification Product Code
LBI  
Date Received04/08/2019
Decision Date 09/05/2019
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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