FDA 510(k)

SB Soft Hood - Straight type, SB Soft Hood - Undercut type

Número K: K173004 · 2018-05-08

Data da decisão2018-05-08

Código do produtoFDS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SB Soft Hood - Straight type, SB Soft Hood - Undercut type is the device name listed in this FDA 510(k) record. The listed applicant is Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2018-05-08 under 510(k) number K173004. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

SB Soft Hood - Straight type, SB Soft Hood - Undercut type is a medical device that received FDA 510(k) clearance on 2018-05-08. The listed applicant is Sumitomo Bakelite Co., Ltd.. The 510(k) number is K173004.

When did SB Soft Hood - Straight type, SB Soft Hood - Undercut type receive FDA 510(k) clearance?

SB Soft Hood - Straight type, SB Soft Hood - Undercut type received FDA 510(k) clearance on 2018-05-08, under 510(k) number K173004.

Who is the listed applicant for SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

The FDA 510(k) record lists Sumitomo Bakelite Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

The FDA product code for SB Soft Hood - Straight type, SB Soft Hood - Undercut type is FDS.

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Fonte oficial

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