DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE— 510(k) K083320
Substantially EquivalentDukal Corp.
FDA 510(k) clearance K083320 for DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE, Substantially Equivalent on 2009-03-06. Applicant: Dukal Corp.. Device class: 2.
Clearance details
- Applicant
- Dukal Corp.
- 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
- Traditional
- Location
- Hauppauge, NY, US
Recent devices under product code KKX
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Data sourced from openFDA. This site is unofficial and independent of the FDA.