← FDA Medical Device Classifications
Prosthesis, Breast, External, No Adhesive
NOJ · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.3800
Classification
- FDA Product Code
NOJ- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 878.3800
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 4
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
external aesthetic restoration prosthesis
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 19
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown