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Data / Medical devices / United States / Menasha Packaging Compnay

Menasha Packaging Compnay: FDA-registered device maker in Edwardsville, IL, United States, 2 510(k) clearances

Menasha Packaging Compnay is registered with the FDA (registration 3010749695) in Edwardsville, IL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 3, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3010749695
Address
9 Gateway Commerce Ctr Dr E, Edwardsville, IL, United States, 62025
Owner or operator
Menasha Packaging Co. LLC (10045291)
Roles
Repackager or relabeler
First device listed
November 5, 2018
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Tampon, Menstrual, UnscentedHEB2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 3, 2017K162746Ontex and other proprietary namesHEBSubstantially EquivalentOntex Bvbaaccessdata.fda.gov
December 23, 2009K090819ONTEX TAMPON (UNSCENTED)HEBSubstantially EquivalentOntex International NVaccessdata.fda.gov

Compare with other makers

Updated March 3, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.