STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS— 510(k) K112904

Substantially Equivalent

Case Medical, Inc.

FDA 510(k) clearance K112904 for STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS, Substantially Equivalent on 2012-01-24. Applicant: Case Medical, Inc..

Clearance details

Applicant: Case Medical, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2011-10-04
Decision date: 2012-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Hackensack, NJ, 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.