POLYPROPYLENE— 510(k) K993997
Substantially EquivalentTrading Consultants and Distributors Intl., Inc.
FDA 510(k) clearance K993997 for POLYPROPYLENE, Substantially Equivalent on 2000-02-04. Applicant: Trading Consultants and Distributors Intl., Inc..
Clearance details
- Applicant
- Trading Consultants and Distributors Intl., Inc.
- Product code
- Code GAW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Adverse events under product code GAW
product code GAW- Death
- 66
- Injury
- 1,616
- Malfunction
- 10,428
- Total
- 12,110
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.