ALARA Neuro Access Kit— 510(k) K190163

Substantially Equivalent

SurGenTec, LLC

FDA 510(k) clearance K190163 for ALARA Neuro Access Kit, Substantially Equivalent on 2019-07-16. Applicant: SurGenTec, LLC.

Clearance details

Applicant: SurGenTec, LLC
Product code: Code PDQ
Advisory panel: Ear, Nose, Throat
Date received: 2019-01-31
Decision date: 2019-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

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