LAPEX 2000— 510(k) K034009

Substantially Equivalent

Meridian Co., Ltd.

FDA 510(k) clearance K034009 for LAPEX 2000, Substantially Equivalent on 2005-01-21. Applicant: Meridian Co., Ltd.. Device class: 2.

Clearance details

Applicant: Meridian Co., Ltd.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2003-12-24
Decision date: 2005-01-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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