Cardinal Health Sterilization Wrap— 510(k) K161910

Clearance details

Applicant

Cardinal Health200, LLC

Product code

Code FRG

Device class

Class 2

Regulation

21 CFR 880.6850

Advisory panel

General Hospital

Date received

2016-07-12

Decision date

2017-04-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Waukegan, IL, US

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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 →