ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES— 510(k) K093046

Substantially Equivalent

Synvasive Technology, Inc.

FDA 510(k) clearance K093046 for ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES, Substantially Equivalent on 2011-03-22. Applicant: Synvasive Technology, Inc.. Device class: 2.

Clearance details

Applicant: Synvasive Technology, Inc.
Product code: Code ONN
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2009-09-30
Decision date: 2011-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, 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.