ISOBAR SEMI-RIGID DUAL DAMPENER— 510(k) K071261

Substantially Equivalent

Scient'X

FDA 510(k) clearance K071261 for ISOBAR SEMI-RIGID DUAL DAMPENER, Substantially Equivalent on 2008-04-17. Applicant: Scient'X. Device class: 2.

Clearance details

Applicant: Scient'X
Product code: Code NQP
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2007-05-04
Decision date: 2008-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maitland, 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.