Cardinal Health Poly Reinforced Surgical Gown— 510(k) K253243
Substantially EquivalentCardinal Health 200, LLC
FDA 510(k) clearance K253243 for Cardinal Health Poly Reinforced Surgical Gown, Substantially Equivalent on 2026-04-28. Applicant: Cardinal Health 200, LLC. Device class: 2.
Clearance details
- Applicant
- Cardinal Health 200, LLC
- 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
- Abbreviated
- Location
- Waukegan, IL, US
Recent devices under product code FYA
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Data sourced from openFDA. This site is unofficial and independent of the FDA.