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Data / Medical devices / United States / Fosdick Fulfillment Corporation

Fosdick Fulfillment Corporation: FDA-registered device maker in Wallingford, CT, United States, 2 510(k) clearances

Fosdick Fulfillment Corporation is registered with the FDA (registration 1000219986) in Wallingford, CT, 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
1000219986
Address
26 Barnes Industrial Rd N, Wallingford, CT, United States, 06492
Owner or operator
Fosdick Fulfillment Corporation (10092601)
Roles
Repackager or relabeler
First device listed
January 24, 2025
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
April 23, 2014K132595ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONSHEBSubstantially EquivalentOntex Bvbaaccessdata.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.