← FDA Medical Device Classifications
Composite Cultured Skin
PBD · f · General, Plastic Surgery · 21 CFR 878.4024
Classification
- FDA Product Code
PBD- Device class
- f
- Regulation
- 21 CFR 878.4024
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 6
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown