Medline Prevention CoolZone Gown— 510(k) K172954
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K172954 for Medline Prevention CoolZone Gown, Substantially Equivalent on 2018-06-15. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- 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
- Northfield, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.