ALARA Neuro Access Kit— 510(k) K190163
Substantially EquivalentSurGenTec, LLC
FDA 510(k) clearance K190163 for ALARA Neuro Access Kit, Substantially Equivalent on 2019-07-16. Applicant: SurGenTec, LLC. Device class: 2.
Clearance details
- Applicant
- SurGenTec, LLC
- Product code
- Code PDQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boca Raton, FL, US
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More clearances from SurGenTec, LLC
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