LDG — Kit, Earmold, Impression Class I
FDA product code LDG covers "Kit, Earmold, Impression", a Class I medical device regulated under 21 CFR 874.3300. Submissions are reviewed by the Ear, Nose, Throat panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LDG
- Device Class
- Class I
- Regulation Number
- 874.3300
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No