TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N— 510(k) K061762
Substantially EquivalentCardinal Health, Inc.
FDA 510(k) clearance K061762 for TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N, Substantially Equivalent on 2006-08-01. Applicant: Cardinal Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardinal Health, 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
- Special
- Location
- Waukegan, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.