Prosthesis, Breast, External, No Adhesive
The external breast prosthesis without adhesive is an external aesthetic restoration device worn by mastectomy patients to restore breast appearance and symmetry without the use of an adhesive attachment system. It is classified as FDA Class 1 under regulation 878.3800 in the General and Plastic Surgery specialty, and it is GMP exempt. Product code NOJ does not require 510(k) clearance and is not an implant device.
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Basic Information
- Product Code
- NOJ
- Device Class
- FDA class 1
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
Definition
external aesthetic restoration prosthesis
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.