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HDM — Packer, Uterine Class I

FDA Device Classification

FDA product code HDM covers "Packer, Uterine", a Class I medical device regulated under 21 CFR 884.4520. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code: HDM
Device Class: Class I
Regulation Number: 884.4520
Submission Type
Review Panel: OB
Medical Specialty: Obstetrics/Gynecology
Implant: No