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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 K873700
Device Name INSTITUTIONAL BILI LIGHT (IBL)
Applicant
Physician Engineered Products, Inc.
Hco6 Box 17
Park Rapids,  MN  56470
Applicant Contact ROSE, M.D.
Correspondent
Physician Engineered Products, Inc.
Hco6 Box 17
Park Rapids,  MN  56470
Correspondent Contact ROSE, M.D.
Regulation Number880.5700
Classification Product Code
LBI  
Date Received09/14/1987
Decision Date 12/11/1987
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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