Medline Non-Surgical Isolation Gown-— 510(k) K160471
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K160471 for Medline Non-Surgical Isolation Gown-, Substantially Equivalent on 2017-01-31. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code FYC
- 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
- Mundelein, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.