HDT — Device, Intrauterine, Contraceptive And Introducer Class III
FDA product code HDT covers "Device, Intrauterine, Contraceptive And Introducer", a Class III medical device regulated under 21 CFR 884.5360. Submissions are reviewed by the Obstetrics/Gynecology panel. Devices under this code are implants.
Classification Details
- Product Code
- HDT
- Device Class
- Class III
- Regulation Number
- 884.5360
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- Yes
Definition
Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86