FDA 510(k)

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE

Número K: K152803 · 2016-07-12

Data da decisão2016-07-12

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Sung Shim Medicare Co., Ltd.. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K152803. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE?

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is Sung Shim Medicare Co., Ltd.. The 510(k) number is K152803.

When did SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE receive FDA 510(k) clearance?

SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE received FDA 510(k) clearance on 2016-07-12, under 510(k) number K152803.

Who is the listed applicant for SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE?

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

What is the FDA product code for SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE?

The FDA product code for SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE is FMF.

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Outros registros que listam Sung Shim Medicare Co., Ltd. como candidato(a)

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Fonte oficial

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