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The Owenby Co.

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Devices
14

What The Owenby Co. makes

The Owenby Co. manufactures wound care and protective coverings, including burn dressings, sterile and non-sterile gauze, tubular stockinette, limb covers, and restraints. Their product line also includes surgical hoods, bouffant caps, and arm slings designed for patient protection and medical support.

The company’s devices are classified as Class I, Class II, and unclassified (U) under FDA regulations, with most products listed via the 510(k) pathway. These items are registered in the FDA’s 510(k) database, and the manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue14

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  • Burn Dressing Kit Ref K770889

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • P.S.M. Justa Cover Ref K761072

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • P.S.M. Justa Kap Ref K761071

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Burn Dressing Pad Ref K780418

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Stockinette, Tubular Unbleached Ref K790210

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cover, Limb Ref K801627

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Non-Sterile Folded Gauze Ref K780764

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • P.S.M. Surgical Hood Ref K761070

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Restraint, Protective Ref K801628

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Arm Sling Ref K801626

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • P.S.M. Bouffant Cap Ref K761068

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Stockinette, Sterile Two Ply W/Pull Tabs Ref K801532

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • P.S.M. Botique Cap Ref K761069

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Arm Sling Ref K801531

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-14 of 14

Frequently asked questions

How many devices does The Owenby Co. have in the registry?

The registry currently lists 14 devices for The Owenby Co.. Devices recorded under merged duplicate company entries are counted once.

Which registries list The Owenby Co.'s devices?

Among its 14 most recently registered devices, The Owenby Co. has devices listed in FDA 510(k) (14 devices).

What risk classes do The Owenby Co.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for The Owenby Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from The Owenby Co. in the registry?

The most recently registered devices listed for The Owenby Co. include BURN DRESSING KIT, P.S.M. JUSTA COVER, P.S.M. JUSTA KAP and BURN DRESSING PAD.

Generated automatically from registry data and not verified by a human reviewer.