Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) (K230577) — FDA 510(k) Clearance | Predicase

K-number	K230577
Device name	Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
Applicant	Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
Product code	FYA
Device class	Class II
Decision date	Aug 16, 2023
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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