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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 K850599
Device Name HOME BILI LIGHTS-MODEL 100
Applicant
PHYSICIAN ENGINEERED PRODUCTS, INC.
HCO6 BOX 17
PARK RAPIDS,  MN  56470
Applicant Contact ROSE
Correspondent
PHYSICIAN ENGINEERED PRODUCTS, INC.
HCO6 BOX 17
PARK RAPIDS,  MN  56470
Correspondent Contact ROSE
Regulation Number880.5700
Classification Product Code
LBI  
Date Received02/15/1985
Decision Date 06/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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