COLONOSCOPIC INJECTION NEEDLE, C-323/C-325— 510(k) K921800
Substantially EquivalentMill-Rose Laboratory
FDA 510(k) clearance K921800 for COLONOSCOPIC INJECTION NEEDLE, C-323/C-325, Substantially Equivalent on 1993-02-08. Applicant: Mill-Rose Laboratory.
Clearance details
- Applicant
- Mill-Rose Laboratory
- Product code
- Code FBK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Adverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
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.