POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001— 510(k) K983029
Substantially EquivalentTpc Advanced Technology, Inc.
FDA 510(k) clearance K983029 for POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001, Substantially Equivalent on 1999-01-29. 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
- Traditional
- Location
- San Diego, 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.