STOMAHESIVE SKIN BARRIER STERILE— 510(k) K851840
Substantially EquivalentConvatec, A Division of E.R. Squibb & Sons
FDA 510(k) clearance K851840 for STOMAHESIVE SKIN BARRIER STERILE, Substantially Equivalent on 1985-06-24. Applicant: Convatec, A Division of E.R. Squibb & Sons.
Clearance details
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
- Product code
- Code EXB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princeton, NJ, US
Adverse events under product code EXB
product code EXB- Injury
- 145
- Total
- 145
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.