Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems— 510(k) K161318
Substantially EquivalentTedan Surgical Innovations, LLC
FDA 510(k) clearance K161318 for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems, Substantially Equivalent on 2017-03-20. Applicant: Tedan Surgical Innovations, LLC. Device class: 2.
Clearance details
- Applicant
- Tedan Surgical Innovations, LLC
- Product code
- Code GZT
- Device class
- Class 2
- Regulation
- 21 CFR 882.4800
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sugar Land, TX, US
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More clearances from Tedan Surgical Innovations, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.