POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30— 510(k) K051547
Substantially EquivalentTpc Advanced Technology, Inc.
FDA 510(k) clearance K051547 for POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30, Substantially Equivalent on 2005-07-14. Applicant: Tpc Advanced Technology, Inc..
Clearance details
- Applicant
- Tpc Advanced Technology, Inc.
- Product code
- Code ELC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- City Of Industry, CA, US
Adverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
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.