ULCELOOCIN ORAL ULCER PATCH— 510(k) K070842
Substantially EquivalentSunshine International Group, Inc.
FDA 510(k) clearance K070842 for ULCELOOCIN ORAL ULCER PATCH, Substantially Equivalent on 2007-06-07. Applicant: Sunshine International Group, Inc..
Clearance details
- Applicant
- Sunshine International Group, Inc.
- Product code
- Code OLR
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Adverse events under product code OLR
product code OLR- Death
- 3
- Total
- 3
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.