GEMINI STERILZATION WRAP— 510(k) K113353

Substantially Equivalent

Medline Industries, Inc.

FDA 510(k) clearance K113353 for GEMINI STERILZATION WRAP, Substantially Equivalent on 2013-01-31. Applicant: Medline Industries, Inc..

Clearance details

Applicant: Medline Industries, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2011-11-14
Decision date: 2013-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, 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.