SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm— 510(k) K151536
Substantially EquivalentMri Interventions, Inc.
FDA 510(k) clearance K151536 for SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm, Substantially Equivalent on 2015-07-08. Applicant: Mri Interventions, Inc.. Device class: 2.
Clearance details
- Applicant
- Mri Interventions, Inc.
- Product code
- Code HBG
- Device class
- Class 2
- Regulation
- 21 CFR 882.4300
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
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