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510(k) K190899

bili-hut by Little Sparrows Technologies, Inc. — Product Code LBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2019
Date Received
April 8, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Neonatal Phototherapy
Device Class
Class II
Regulation Number
880.5700
Review Panel
HO
Submission Type

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