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Data / Medical devices / United States / Sdab Partners LLC

Sdab Partners LLC: FDA-registered device maker in South Euclid, OH, United States, 1 510(k) clearance

Sdab Partners LLC is registered with the FDA (registration 3014527910) in South Euclid, OH, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 14, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3014527910
Address
2120 South Green Road, South Euclid, OH, United States, 44121
Owner or operator
SDAB Partners LLC (10057484)
Roles
Complaint file establishment
First device listed
July 27, 2018
Registered through
2026
Brand names listed
Polydioxanone suture, V Soft Line

Devices it lists

DeviceProduct codeClassRoleSource
Needle, Suturing, DisposableGAB1Complaint file establishmentaccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Complaint file establishmentaccessdata.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
November 14, 2018K172602MiracuNEWSubstantially EquivalentFeeltech Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 14, 2018. 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.