VIVONEX DELIVERY SYSTEM— 510(k) K780415

Substantially Equivalent

Norwich Pharmacal Co.

FDA 510(k) clearance K780415 for VIVONEX DELIVERY SYSTEM, Substantially Equivalent on 1978-04-10. Applicant: Norwich Pharmacal Co..

Clearance details

Applicant: Norwich Pharmacal Co.
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 1978-03-14
Decision date: 1978-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.