Flap Fixator, Burr Hole Cover— 510(k) K192310
Substantially EquivalentOssaware Biotech Co., Ltd.
FDA 510(k) clearance K192310 for Flap Fixator, Burr Hole Cover, Substantially Equivalent on 2020-06-03. Applicant: Ossaware Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ossaware Biotech Co., Ltd.
- 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
- Shenkang Hsiang, TW
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Data sourced from openFDA. This site is unofficial and independent of the FDA.