FHW — Device, Impotence, Mechanical/Hydraulic Class III

FDA Device Classification

Classification Details

Product Code
FHW
Device Class
Class III
Regulation Number
876.3350
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Definition

PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))