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FDA 510(k)

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

K-Number: K230577 · 2023-08-16

ApplicantMedcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
Decision Date2023-08-16
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) is a medical device manufactured by Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi. It received FDA 510(k) clearance on 2023-08-16 under approval number K230577. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)?

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) is a medical device that received FDA 510(k) clearance on 2023-08-16. It is manufactured by Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi. The 510(k) number is K230577.

When was Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) approved by the FDA?

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) received FDA 510(k) clearance on 2023-08-16, under approval number K230577.

What company makes Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)?

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) is manufactured by Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi.

What is the FDA product code for Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)?

The FDA product code for Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) is FYA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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