CARA-STAIN MODEL 3000— 510(k) K771699
Substantially EquivalentAmerican Safety Equipment Corp.
FDA 510(k) clearance K771699 for CARA-STAIN MODEL 3000, Substantially Equivalent on 1977-09-13. Applicant: American Safety Equipment Corp..
Clearance details
- Applicant
- American Safety Equipment Corp.
- Product code
- Code KPA
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code KPA
product code KPA- Malfunction
- 1,177
- Total
- 1,177
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.