XINIWAVE, MODEL XW-18— 510(k) K100441
Substantially EquivalentInternational Trade Group, Inc.
FDA 510(k) clearance K100441 for XINIWAVE, MODEL XW-18, Substantially Equivalent on 2010-07-15. Applicant: International Trade Group, Inc.. Device class: 2.
Clearance details
- Applicant
- International Trade Group, Inc.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oxford, OH, US
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