NERVE CUFF— 510(k) K132660
Substantially EquivalentCook Biotech Incorporated
FDA 510(k) clearance K132660 for NERVE CUFF, Substantially Equivalent on 2014-01-10. Applicant: Cook Biotech Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Biotech Incorporated
- Product code
- Code JXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.5275
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Lafayette, IN, US
Recent devices under product code JXI
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Data sourced from openFDA. This site is unofficial and independent of the FDA.