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FDA 510(k)

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire

Número K: K190125 · 2019-05-19

RequerenteT.A.G. Medical Products Corporation, Ltd.
Data da decisão2019-05-19
Código do produtoMBI
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire is the device name listed in this FDA 510(k) record. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2019-05-19 under 510(k) number K190125. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire?

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire is a medical device that received FDA 510(k) clearance on 2019-05-19. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K190125.

When did FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire receive FDA 510(k) clearance?

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire received FDA 510(k) clearance on 2019-05-19, under 510(k) number K190125.

Who is the listed applicant for FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire?

The FDA 510(k) record lists T.A.G. Medical Products Corporation, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire?

The FDA product code for FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire is MBI.

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Fonte oficial

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