DERMISTRIP— 510(k) K861972
Substantially Equivalent for Some IndicationsKells Medical, Inc.
FDA 510(k) clearance K861972 for DERMISTRIP, Substantially Equivalent for Some Indications on 1986-06-27. Applicant: Kells Medical, Inc..
Clearance details
- Applicant
- Kells Medical, Inc.
- Product code
- Code NAD
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Burr Ridge, IL, US
Adverse events under product code NAD
product code NAD- Injury
- 431
- Malfunction
- 11,935
- Other
- 1
- Total
- 12,367
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.