SHEATHES ULTRASOND GEL— 510(k) K112827

Name: FDA 510(k) clearance K112827
Creator: U.S. Food and Drug Administration
Published: 2012-06-22

Substantially Equivalent

Sheathing Technologies, Inc.

FDA 510(k) clearance K112827 for SHEATHES ULTRASOND GEL, Substantially Equivalent on 2012-06-22. Applicant: Sheathing Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Sheathing Technologies, Inc.
Product code: Code MUI
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2011-09-28
Decision date: 2012-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgan Hill, CA, US

Download summary PDF View on FDA.gov ↗

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