ELIBRA SOFT-TISSUE FORCE SENSOR— 510(k) K132104

Name: FDA 510(k) clearance K132104
Creator: U.S. Food and Drug Administration
Published: 2014-03-21

Substantially Equivalent

Kamm & Associates

FDA 510(k) clearance K132104 for ELIBRA SOFT-TISSUE FORCE SENSOR, Substantially Equivalent on 2014-03-21. Applicant: Kamm & Associates. Device class: 2.

Clearance details

Applicant: Kamm & Associates
Product code: Code ONN
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2013-07-08
Decision date: 2014-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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