SABRE— 510(k) K993177
Substantially EquivalentSle Limited
FDA 510(k) clearance K993177 for SABRE, Substantially Equivalent on 1999-11-16. Applicant: Sle Limited. Device class: 2.
Clearance details
- Applicant
- Sle Limited
- Product code
- Code GWJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1900
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- La Jolla, CA, US
Recent devices under product code GWJ
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