Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit— 510(k) K170902

Name: FDA 510(k) clearance K170902
Creator: U.S. Food and Drug Administration
Published: 2017-06-26

Substantially Equivalent

Spr Therapeutics, LLC

FDA 510(k) clearance K170902 for Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit, Substantially Equivalent on 2017-06-26. Applicant: Spr Therapeutics, LLC. Device class: 2.

Clearance details

Applicant: Spr Therapeutics, LLC
Product code: Code NHI
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2017-03-28
Decision date: 2017-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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