PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C— 510(k) K092761
Substantially EquivalentBio Protech, Inc.
FDA 510(k) clearance K092761 for PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C, Substantially Equivalent on 2009-11-24. Applicant: Bio Protech, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio Protech, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dallas, TX, US
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Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.