DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406— 510(k) K052259
Substantially EquivalentSchering-Plough Healthcare Products, Inc.
FDA 510(k) clearance K052259 for DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406, Substantially Equivalent on 2005-12-14. Applicant: Schering-Plough Healthcare Products, Inc..
Clearance details
- Applicant
- Schering-Plough Healthcare Products, Inc.
- Product code
- Code GEH
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkeley Heights, NJ, US
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
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.