JEJUNO-CATH KIT— 510(k) K905677

Substantially Equivalent

Health Improvement Assoc.

FDA 510(k) clearance K905677 for JEJUNO-CATH KIT, Substantially Equivalent on 1991-08-09. Applicant: Health Improvement Assoc..

Clearance details

Applicant: Health Improvement Assoc.
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 1990-12-19
Decision date: 1991-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freeland, MI, 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.