CARDINAL HEALTH DURABLUE STERILIZATION WRAP— 510(k) K120542
Substantially EquivalentCardinal Health-Medical Products and Services
FDA 510(k) clearance K120542 for CARDINAL HEALTH DURABLUE STERILIZATION WRAP, Substantially Equivalent on 2012-06-01. Applicant: Cardinal Health-Medical Products and Services. Device class: 2.
Clearance details
- Applicant
- Cardinal Health-Medical Products and Services
- Product code
- Code FRG
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukegan, IL, US
Recent devices under product code FRG
view allMore clearances from Cardinal Health-Medical Products and Services
view all- K132060 — DURABLUE STERILIZATION WRAP
- K123289 — DURABLUE STERILIZATION WRAP
- K113707 — STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
- K111868 — STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING
- K983962 — ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
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.