SILICONE TISSUE EXPANDER— 510(k) K070303
Substantially EquivalentSpecialty Surgical Products
FDA 510(k) clearance K070303 for SILICONE TISSUE EXPANDER, Substantially Equivalent on 2007-06-22. Applicant: Specialty Surgical Products.
Clearance details
- Applicant
- Specialty Surgical Products
- Product code
- Code LCJ
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Victor, MT, US
Adverse events under product code LCJ
product code LCJ- Injury
- 2,704
- Other
- 2
- Total
- 2,706
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.