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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 K810953
Device Name MODEL 533 PHOTOTHERAPY UNIT
Applicant
Narco Air-Shields
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Narco Air-Shields
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5700
Classification Product Code
LBI  
Date Received04/07/1981
Decision Date 04/23/1981
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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