Recognized standard
F2051-00 (Reapproved 2014)
FDA recognition 6-353 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-353 |
|---|---|
| Designation | F2051-00 (Reapproved 2014) |
| Title | Standard Specification for Implantable Saline Filled Breast Prosthesis |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast. 1.2 Limitations: 1.2.1 This specification does not cover custom… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: