DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560— 510(k) K061864
Substantially EquivalentDukal Corp.
FDA 510(k) clearance K061864 for DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560, Substantially Equivalent on 2006-09-15. Applicant: Dukal Corp.. Device class: 2.
Clearance details
- Applicant
- Dukal Corp.
- 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
- Hauppauge, NY, US
Recent devices under product code FXX
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More clearances from Dukal Corp.
view all- K083320 — DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
- K070407 — DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE
- K020726 — DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
- K984564 — ETHYL CHLORIDE DISPENSER
- K970455 — DUKAL NON ADHERENT DRESSING
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.