CRANIOPLUG— 510(k) K140309
Substantially EquivalentOssdsign AB
FDA 510(k) clearance K140309 for CRANIOPLUG, Substantially Equivalent on 2014-10-03. Applicant: Ossdsign AB. Device class: 2.
Clearance details
- Applicant
- Ossdsign AB
- Product code
- Code GXR
- Device class
- Class 2
- Regulation
- 21 CFR 882.5250
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
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More clearances from Ossdsign AB
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- K181539 — OSSDSIGN Cranioplug
- K161090 — Cranial PSI
Data sourced from openFDA. This site is unofficial and independent of the FDA.