SHAWNEE PRODUCTS KIT II— 510(k) K921761

Unknown

Absentee Shawnee Bandage Group

FDA 510(k) clearance K921761 for SHAWNEE PRODUCTS KIT II, Unknown on 1993-03-18. Applicant: Absentee Shawnee Bandage Group.

Clearance details

Applicant: Absentee Shawnee Bandage Group
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1992-04-14
Decision date: 1993-03-18
Decision: Unknown
Clearance type: Traditional
Location: Tecumseh, OH, US

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.