EXAM GOWN

K770476 · General Medical Co. · FME · May 6, 1977 · General Hospital

Device Facts

Record IDK770476
Device NameEXAM GOWN
ApplicantGeneral Medical Co.
Product CodeFME · General Hospital
Decision DateMay 6, 1977
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 880.6265
Device ClassClass 1

Regulatory Classification

Identification

An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.

Innolitics

Panel 1

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