HFZ — Craniotribe Class II

FDA Device Classification

FDA product code HFZ covers "Craniotribe", a Class II medical device regulated under 21 CFR 884.4500. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code
HFZ
Device Class
Class II
Regulation Number
884.4500
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No