GORE-TEX NON-STERILE SURGICAL GOWNS— 510(k) K052833
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K052833 for GORE-TEX NON-STERILE SURGICAL GOWNS, Substantially Equivalent on 2006-02-15. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code KKX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mundelein, IL, US
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