FTO — Prosthesis, Testicle Class III
FDA product code FTO covers "Prosthesis, Testicle", a Class III medical device regulated under 21 CFR 876.3750. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants.
Classification Details
- Product Code
- FTO
- Device Class
- Class III
- Regulation Number
- 876.3750
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95