ISOELASTICU— 510(k) K081025

Substantially Equivalent

Remi Sciences, Inc.

FDA 510(k) clearance K081025 for ISOELASTICU, Substantially Equivalent on 2008-11-21. Applicant: Remi Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Remi Sciences, Inc.
Product code: Code KXE
Device class: Class 2
Regulation: 21 CFR 888.3810
Advisory panel: Orthopedic
Date received: 2008-04-10
Decision date: 2008-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lititz, PA, 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.