510(k) K922398— 4 SURE TM ENEMA BAG SET
UnknownBoston Pacific Medical, Inc.
Clearance details
- Applicant
- Boston Pacific Medical, Inc.
- Product code
- Code FCE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Boston, MA, 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.