TWIN PLUS— 510(k) K012976

Substantially Equivalent

Grass-Telefactor Divison

FDA 510(k) clearance K012976 for TWIN PLUS, Substantially Equivalent on 2002-02-12. Applicant: Grass-Telefactor Divison. Device class: 2.

Clearance details

Applicant: Grass-Telefactor Divison
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2001-09-05
Decision date: 2002-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West-Warwick, RI, 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.