ANGEL WING SETS -- MODIFIED— 510(k) K922468

Substantially Equivalent

Mbo Laboratories, Inc.

FDA 510(k) clearance K922468 for ANGEL WING SETS -- MODIFIED, Substantially Equivalent on 1992-07-10. Applicant: Mbo Laboratories, Inc..

Clearance details

Applicant: Mbo Laboratories, Inc.
Product code: Code GIM
Advisory panel: Clinical Chemistry
Date received: 1992-05-13
Decision date: 1992-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Chelmsford, MA, US

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Adverse events under product code GIM

product code GIM

Malfunction: 1,325
Total: 1,325

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.