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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 K243372
Device Name BiliWrap
Applicant
Gerium Medical, Ltd.
4 Paran St.
Bldg. 11
Yavne,  IL 8122503
Applicant Contact Noam Rubin Tal
Correspondent
ProMedoss, Inc.
6026 Beech Cove Ln
Charlotte,  NC  28269
Correspondent Contact Bosmat Friedman-Cox
Regulation Number880.5700
Classification Product Code
LBI  
Date Received10/30/2024
Decision Date 05/29/2025
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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