HEF — Binder, Breast Class I

FDA Device Classification

FDA product code HEF covers "Binder, Breast", a Class I medical device regulated under 21 CFR 880.5160. Submissions are reviewed by the General Hospital panel.

Classification Details

Product Code
HEF
Device Class
Class I
Regulation Number
880.5160
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No