REDON SET— 510(k) K001716
Substantially EquivalentPfm Produkte Fur Die Medizin AG
FDA 510(k) clearance K001716 for REDON SET, Substantially Equivalent on 2000-07-19. Applicant: Pfm Produkte Fur Die Medizin AG.
Clearance details
- Applicant
- Pfm Produkte Fur Die Medizin AG
- Product code
- Code JCX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Santa Margarita, CA, US
Adverse events under product code JCX
product code JCX- Death
- 11
- Malfunction
- 838
- Other
- 1
- Total
- 850
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.