Prosthesis, Breast, Inflatable, Internal, Saline
- US Product Code (FDA)
- FWMView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 878.3530View CFR Regulation →
- Medical specialty
- General, Plastic Surgery
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
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Prosthesis, Breast, Inflatable, Internal, Saline is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.