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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 K760872
Device Name PHOTOTHERAPY LIGHT
Applicant
Air-Shields, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Air-Shields, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5700
Classification Product Code
LBI  
Date Received10/18/1976
Decision Date 11/02/1976
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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