MEDIASTINAL SILICONE DRAINS— 510(k) K942709
Substantially Equivalent for Some IndicationsSil-Med Corp.
FDA 510(k) clearance K942709 for MEDIASTINAL SILICONE DRAINS, Substantially Equivalent for Some Indications on 1996-01-04. Applicant: Sil-Med Corp..
Clearance details
- Applicant
- Sil-Med Corp.
- Product code
- Code GBW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Taunton, MA, US
Adverse events under product code GBW
product code GBW- Death
- 6
- Total
- 6
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.