COLON IRRIGATION DEV.,COLON-A-SUN COLONI— 510(k) K770300
Substantially EquivalentSun Product Dist., Inc.
FDA 510(k) clearance K770300 for COLON IRRIGATION DEV.,COLON-A-SUN COLONI, Substantially Equivalent on 1977-03-30. Applicant: Sun Product Dist., Inc..
Clearance details
- Applicant
- Sun Product Dist., Inc.
- Product code
- Code FCE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code FCE
product code FCE- Other
- 2
- Total
- 2
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.