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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 K172656
Device Name BiliLux
Applicant
Draeger Medical Systems, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact Gale Winarsky
Correspondent
Draeger Medical Systems, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact Gale Winarsky
Regulation Number880.5700
Classification Product Code
LBI  
Date Received09/05/2017
Decision Date 05/01/2018
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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