HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240— 510(k) K003337
Substantially EquivalentWeck Closure Systems
FDA 510(k) clearance K003337 for HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240, Substantially Equivalent on 2000-12-21. Applicant: Weck Closure Systems.
Clearance details
- Applicant
- Weck Closure Systems
- Product code
- Code FZP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Research Triangle Park, NC, US
Adverse events under product code FZP
product code FZP- Death
- 11
- Injury
- 726
- Malfunction
- 10,830
- Other
- 1
- Total
- 11,568
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.