FDA 510(k)

Strome-Blitzer Cytology Balloon

Número K: K182159 · 2019-06-13

Data da decisão2019-06-13

Código do produtoEOX

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Strome-Blitzer Cytology Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Adn International, LLC. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K182159. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Strome-Blitzer Cytology Balloon?

Strome-Blitzer Cytology Balloon is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Adn International, LLC. The 510(k) number is K182159.

When did Strome-Blitzer Cytology Balloon receive FDA 510(k) clearance?

Strome-Blitzer Cytology Balloon received FDA 510(k) clearance on 2019-06-13, under 510(k) number K182159.

Who is the listed applicant for Strome-Blitzer Cytology Balloon?

The FDA 510(k) record lists Adn International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Strome-Blitzer Cytology Balloon?

The FDA product code for Strome-Blitzer Cytology Balloon is EOX.

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