FDA 510(k)

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)

K-Nummer: K203539 · 2021-12-10

Entscheidungsdatum2021-12-10

ProduktcodeFYA

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) is the device name listed in this FDA 510(k) record. The listed applicant is Unicoglobal, Inc.. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K203539. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)?

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Unicoglobal, Inc.. The 510(k) number is K203539.

When did Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) receive FDA 510(k) clearance?

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) received FDA 510(k) clearance on 2021-12-10, under 510(k) number K203539.

Who is the listed applicant for Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)?

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

What is the FDA product code for Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)?

The FDA product code for Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) is FYA.

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Verwandte Geräte (Code: FYA)

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Offizielle Quelle

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