Name: Predicase
Price: 199 USD

K-number	K203237
Device name	Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
Applicant	Dukal Corporation
Product code	FYA
Device class	Class II
Decision date	Mar 18, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown

Everything you need for a 510(k) submission. Nothing you don't.