Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets— 510(k) K230838
Substantially EquivalentCardinal Health200, LLC
FDA 510(k) clearance K230838 for Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets, Substantially Equivalent on 2023-07-27. Applicant: Cardinal Health200, LLC. Device class: 2.
Clearance details
- Applicant
- Cardinal Health200, 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
- Traditional
- Location
- Waukegan, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.