510(k) K203237— 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

Substantially Equivalent

Dukal Corporation

Clearance details

Applicant: Dukal Corporation
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2020-11-03
Decision date: 2022-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronkonkoma, NY, US

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