MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL— 510(k) K962163
Substantially EquivalentMisten Medical Corp.
FDA 510(k) clearance K962163 for MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL, Substantially Equivalent on 1996-07-25. Applicant: Misten Medical Corp..
Clearance details
- Applicant
- Misten Medical Corp.
- Product code
- Code ERL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Germantown, TN, US
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.