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HDN — Dilator, Cervical, Expandable Class III

FDA Device Classification

FDA product code HDN covers "Dilator, Cervical, Expandable", a Class III medical device regulated under 21 CFR 884.4250. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code: HDN
Device Class: Class III
Regulation Number: 884.4250
Submission Type
Review Panel: OB
Medical Specialty: Obstetrics/Gynecology
Implant: No

Definition

Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96