X-FORCE— 510(k) K111557

Name: FDA 510(k) clearance K111557
Creator: U.S. Food and Drug Administration
Published: 2011-11-10

Substantially Equivalent

Seven Seas Distribtion and Manufacturing, LLC

FDA 510(k) clearance K111557 for X-FORCE, Substantially Equivalent on 2011-11-10. Applicant: Seven Seas Distribtion and Manufacturing, LLC. Device class: 2.

Clearance details

Applicant: Seven Seas Distribtion and Manufacturing, LLC
Product code: Code NYN
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2011-06-03
Decision date: 2011-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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