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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 K210289
Device Name Infant Phototherapy Equipment
Applicant
Bistos Co., Ltd.
7th Floor , A Bldg., Woolim Lions Valley 5-Cha, 302
Galmachi-Ro, Jungwon-Gu
Seongnam-Si,  KR 13201
Applicant Contact Dae Eun Kim
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.5700
Classification Product Code
LBI  
Date Received02/02/2021
Decision Date 05/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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