FXZ — Helmet, Surgical Class I

FDA Device Classification

FDA product code FXZ covers "Helmet, Surgical", a Class I medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel.

Classification Details

Product Code
FXZ
Device Class
Class I
Regulation Number
878.4040
Submission Type
Review Panel
HO
Medical Specialty
General, Plastic Surgery
Implant
No