FIRST CHOICE(TM)— 510(k) K912732

Substantially Equivalent

Polymer Technology Corp.

FDA 510(k) clearance K912732 for FIRST CHOICE(TM), Substantially Equivalent on 1991-09-10. Applicant: Polymer Technology Corp..

Clearance details

Applicant: Polymer Technology Corp.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 1991-06-20
Decision date: 1991-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issaquah, WA, US

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Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.