LARGE VOLUME ENEMA CONTAINER DISPOSABLE— 510(k) K800959
Substantially EquivalentThe Healthcare Group Laboratories, Inc.
FDA 510(k) clearance K800959 for LARGE VOLUME ENEMA CONTAINER DISPOSABLE, Substantially Equivalent on 1980-05-14. Applicant: The Healthcare Group Laboratories, Inc..
Clearance details
- Applicant
- The Healthcare Group Laboratories, 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.