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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Neonatal Eye
510(k) Number K851918
Device Name INFANT PHOTOTHERAPY MASK
Applicant
Alba Health Care
Post Office Box 100
Valdese,  NC  28690
Applicant Contact VICTOR H GARROU
Correspondent
Alba Health Care
Post Office Box 100
Valdese,  NC  28690
Correspondent Contact VICTOR H GARROU
Regulation Number880.5270
Classification Product Code
FOK  
Date Received05/02/1985
Decision Date 06/07/1985
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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