MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD— 510(k) K991559
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K991559 for MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD, Substantially Equivalent on 1999-08-23. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code FXX
- 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
Recent devices under product code FXX
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Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.