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Data / Medical devices / United States / The Hilsinger Company Parent, LLC

The Hilsinger Company Parent, LLC: FDA-registered device maker in Mansfield, MA, United States, 1 510(k) clearance

The Hilsinger Company Parent, LLC is registered with the FDA (registration 1218954) in Mansfield, MA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 25, 2005. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1218954
FEI number
1000086744
Address
575 West Street, Suite 120, Mansfield, MA, United States, 02048
Owner or operator
The Hilsinger Company Parent, LLC (1218954)
Roles
Complaint file establishment, Specification developer
First device listed
December 15, 1977
Registered through
2026
Brand names listed
A2, Croakies, Hilco, Leader, Leader Sports, OnGuard, SUNCLIPS, SprinGuard and more

Devices it lists

DeviceProduct codeClassRoleSource
Case, Contact LensLRX2Complaint file establishment, Specification developeraccessdata.fda.gov
Frame, SpectacleHQZ1Complaint file establishment, Specification developeraccessdata.fda.gov
Lens, Spectacle, Non-Custom (Prescription)HQG1Complaint file establishment, Specification developeraccessdata.fda.gov
Spectacle, MagnifyingHOI1Complaint file establishment, Specification developeraccessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)HQY1Complaint file establishment, Specification developeraccessdata.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
January 25, 2005K042578I-PROMOTIONS CONTACT LENS CASELRXSubstantially EquivalentI-Promotions, Inc.accessdata.fda.gov

Compare with other makers

Updated January 25, 2005. 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.