WAVE GATE— 510(k) K853412
Substantially EquivalentWolfline Corp.
FDA 510(k) clearance K853412 for WAVE GATE, Substantially Equivalent on 1985-10-28. Applicant: Wolfline Corp.. Device class: 2.
Clearance details
- Applicant
- Wolfline Corp.
- Product code
- Code GWE
- Device class
- Class 2
- Regulation
- 21 CFR 882.1890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code GWE
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