← FDA Medical Device Classifications
Material, External Aesthetic Restoration, Used With Adhesive
GBI · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.3800
Classification
- FDA Product Code
GBI- 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
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 17
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown