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FOK — Pad, Neonatal Eye Class I

FDA Device Classification

Classification Details

Product Code
FOK
Device Class
Class I
Regulation Number
880.5270
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K962290debusk technologyDEROYAL INDUSTRIES, INC. NEONATAL EYE COVERJuly 3, 1996
K926118graphic controlsLIFE TRACE(R) BILIRUBIN MASKMarch 15, 1993
K851918alba health careINFANT PHOTOTHERAPY MASKJune 7, 1985
K840894a and a medical suppliesPHOTO-THERAPY EYE PROTECTORMarch 23, 1984
K813214montrose phototherapy supplyINFANT PHOTOTHERAPY MASKDecember 9, 1981