Medline Orbis Chemo Surgical Gown— 510(k) K214108
Substantially EquivalentMedline Industries, LP
FDA 510(k) clearance K214108 for Medline Orbis Chemo Surgical Gown, Substantially Equivalent on 2022-05-06. Applicant: Medline Industries, LP. Device class: 2.
Clearance details
- Applicant
- Medline Industries, LP
- 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
- Northfiled, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.