FDA 510(k)

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft

Número K: K160869 · 2016-04-29

Data da decisão2016-04-29

Código do produtoFTM

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K160869. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft?

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K160869.

When did Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft receive FDA 510(k) clearance?

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft received FDA 510(k) clearance on 2016-04-29, under 510(k) number K160869.

Who is the listed applicant for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft?

The FDA 510(k) record lists Cook Biotech Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft?

The FDA product code for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft is FTM.

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Outros registros que listam Cook Biotech Incorporated como candidato(a)

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