FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD— 510(k) K934974
Substantially EquivalentMid America Medical, Inc.
FDA 510(k) clearance K934974 for FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD, Substantially Equivalent on 1994-04-13. Applicant: Mid America Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Mid America Medical, 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
- Covington, KY, US
Recent devices under product code FXX
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- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252650 — Disposable Medical Face Mask
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.