BOWRON— 510(k) K922618

Substantially Equivalent

G.L. Bowron & Co. , Ltd.

FDA 510(k) clearance K922618 for BOWRON, Substantially Equivalent on 1993-08-19. Applicant: G.L. Bowron & Co. , Ltd..

Clearance details

Applicant: G.L. Bowron & Co. , Ltd.
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1992-06-02
Decision date: 1993-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellingham, MA, US

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Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

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.