TOPSLANE DMLC— 510(k) K060187

Substantially Equivalent

Topslane International, LLC

FDA 510(k) clearance K060187 for TOPSLANE DMLC, Substantially Equivalent on 2006-07-27. Applicant: Topslane International, LLC. Device class: 2.

Clearance details

Applicant: Topslane International, LLC
Product code: Code IXI
Device class: Class 2
Regulation: 21 CFR 892.5710
Advisory panel: Radiology
Date received: 2006-01-24
Decision date: 2006-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.