510(k) K894610— CUSTOM TRAYS, KITS
UnknownL H M Ent., Inc.
Clearance details
- Applicant
- L H M Ent., Inc.
- Product code
- Code FSM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Palm Harbor, FL, US
Adverse events under product code FSM
product code FSM- Malfunction
- 1,289
- Total
- 1,289
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.