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— 510(k) K203237
Substantially EquivalentDukal Corporation
FDA 510(k) clearance K203237 for 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 on 2022-03-18. Applicant: Dukal Corporation. Device class: 2.
Clearance details
- Applicant
- Dukal Corporation
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ronkonkoma, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.