Comatryx OTC— 510(k) K232758
Substantially EquivalentStrukmyer Medical, LLC
FDA 510(k) clearance K232758 for Comatryx OTC, Substantially Equivalent on 2023-12-01. Applicant: Strukmyer Medical, LLC.
Clearance details
- Applicant
- Strukmyer Medical, LLC
- Product code
- Code KGN
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mesquite, TX, US
Adverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
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.