MONARCH STERILIZATION CONTAINER SYST, MODIFICATION— 510(k) K911760

Substantially Equivalent

Monarch Products, Inc.

FDA 510(k) clearance K911760 for MONARCH STERILIZATION CONTAINER SYST, MODIFICATION, Substantially Equivalent on 1991-06-24. Applicant: Monarch Products, Inc..

Clearance details

Applicant: Monarch Products, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 1991-04-12
Decision date: 1991-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, TX, US

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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.